CPS-1000
FDA 510(k) clearance K802890 · decided 1981-03-05
Clearance details
- K-number
- K802890
- Device name
- CPS-1000
- Applicant
- Gics Pharmaceuticals
- Decision
- Substantially Equivalent
- Date received
- 1980-11-17
- Decision date
- 1981-03-05
- Days to decision
- 108 days
- Clearance type
- Traditional
- Product code
- DTN
- Device class
- 2
- Regulation number
- 870.4400
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.