SPHYGURITE
FDA 510(k) clearance K821095 · decided 1982-06-10
Clearance details
- K-number
- K821095
- Device name
- SPHYGURITE
- Applicant
- Associated Medical Devices, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-04-19
- Decision date
- 1982-06-10
- Days to decision
- 52 days
- Clearance type
- Traditional
- Product code
- DXQ
- Device class
- 2
- Regulation number
- 870.1120
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.