510(k) clearances

SQA-iOw Sperm Quality Analyzer

Medical Electronic Systems , Ltd. · Hematology

K243114Substantially EquivalentDual TrackPOV
Open FDA's page for this record
Third party flag
N
City
Caesarea
Advisory committee description
Hematology
Address 1
Alon Hatavor St. 20
Statement or summary
Summary
Product code
POV
Zip code
3088900
Applicant
Medical Electronic Systems , Ltd.
Decision date
2025-05-02
Decision code
SESE
Country code
IL
Device name
SQA-iOw Sperm Quality Analyzer
Advisory committee
HE
Contact
Taly Vider Cohen
K number
K243114
Date received
2024-09-30
Review advisory committee
HE
Postal code
3088900
Decision description
Substantially Equivalent
Clearance type
Dual Track
Harmonized identifiers (openFDA)
Device name
Semen Analysis Device
Medical specialty description
Hematology
Regulation number
864.5220
Device class
2
Registration number
3026478115, 3014053517, 3003646592, 3011260354, 3043196750, 1221433, 2246703, 1216677, 3015550658, 3016090200, 3026478116, 3005360469, 3014295858, 3007800906, 1832894
FEI number
3026478115, 3014053517, 3003646592, 3011260354, 3043196750, 1221433, 3005670738, 2246703, 1216677, 3015550658, 3016090200, 3026478116, 1832894, 3014295858, 3007800906
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.