INTERSPEC APOGEE
FDA 510(k) clearance K903839 · decided 1990-11-16
Clearance details
- K-number
- K903839
- Device name
- INTERSPEC APOGEE
- Applicant
- Interspec, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-08-21
- Decision date
- 1990-11-16
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- DXK
- Device class
- 2
- Regulation number
- 870.2330
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Ambler, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.