Racz Neurostat RF Generator
Epimed International · Neurology
Open FDA's page for this record- Third party flag
- N
- City
- Johnstown
- Advisory committee description
- Neurology
- Address 1
- 141 Sal Landrio Dr. Crossroads Business Park
- Statement or summary
- Summary
- Product code
- GXD
- Zip code
- 12095
- Applicant
- Epimed International
- Decision date
- 2024-05-24
- Decision code
- SESE
- Country code
- US
- Device name
- Racz Neurostat RF Generator
- Advisory committee
- NE
- Contact
- Preston Frasier
- K number
- K232632
- State
- NY
- Date received
- 2023-08-30
- Review advisory committee
- NE
- Postal code
- 12095
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Generator, Lesion, Radiofrequency
- Medical specialty description
- Neurology
- Regulation number
- 882.4400
- Device class
- 2
- Registration number
- 3001592626, 3010966701, 3016678045, 9680001, 9680425, 3018094310, 3009766315, 2133786, 2030624, 3004122598, 2124215, 2182269, 3007221462, 3030733800, 3008837339, 3003120897, 3009555600, 3007695959, 3006630150, 9616693, 1030489, 1627487, 3010653929, 1000632857, 3043527620, 3005334138, 8043398, 3015967359, 8010177, 1224960, 3003477135, 1644312, 3007029079, 3007997036, 3015173212, 1319639, 9611612, 3011270181, 2184149, 3020968442 +10 more
- FEI number
- 3003186357, 3001592626, 3010966701, 3016678045, 1000477302, 3018094310, 3009766315, 3004122598, 2124215, 2182269, 3007221462, 3030733800, 3008837339, 3003630373, 3003120897, 3007596547, 3009555600, 3007695959, 3006630150, 3002807847, 3000204727, 3002808445, 1627487, 3000204692, 3010653929, 1000632857, 3043527620, 3005334138, 3015967359, 3003477135, 3007029079, 3007997036, 3002807111, 3000206435, 3015173212, 1000064530, 1000117748, 3002618605, 3011270181, 3020968442 +10 more