Falcon HST
Compumedics Limited · Neurology
Open FDA's page for this record- Third party flag
- Y
- City
- Abbotsford
- Advisory committee description
- Neurology
- Address 1
- 30-40 Flockhart St.
- Statement or summary
- Summary
- Product code
- OLV
- Zip code
- 3067
- Applicant
- Compumedics Limited
- Decision date
- 2025-02-20
- Decision code
- SESE
- Country code
- AU
- Device name
- Falcon HST
- Advisory committee
- NE
- Contact
- John Joseph
- K number
- K242447
- Date received
- 2024-08-16
- Review advisory committee
- NE
- Postal code
- 3067
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Standard Polysomnograph With Electroencephalograph
- Medical specialty description
- Neurology
- Regulation number
- 882.1400
- Device class
- 2
- Registration number
- 3038189172, 8030229, 2518422, 3006125362, 3002806730, 3008881376, 2184161, 3021736577, 3007389703, 3006258337, 1650946, 2080783, 3007323246, 3005733633, 1530224, 3005550372, 9710486, 3047516694, 3001687738, 3000126629, 3008253300, 3020018, 3016852448, 3012428212, 9613619, 3006177498, 3002797442, 3006418479, 3009770872, 3026753386, 3007616088, 3013501110, 1063925, 3027726372, 3004964738, 2023374, 3010611950, 9612330, 9615102, 3018783526 +8 more
- FEI number
- 3038189172, 2518422, 1000271197, 3006125362, 3002806730, 3008881376, 3021736577, 3002807739, 3006258337, 3007389703, 2080783, 3007323246, 3002809369, 3004674371, 3005733633, 3005550372, 3047516694, 3001687738, 3002716534, 3000126629, 3002807720, 3008253300, 3003501123, 3003208775, 3016852448, 3020018, 3012428212, 3006177498, 3002797442, 3006418479, 3009770872, 3026753386, 3007616088, 3013501110, 1000160007, 3027726372, 3004964738, 2023374, 3010611950, 3000206198 +8 more