BP8800T/8000IR/8300G NON-INVASIVE BLOOD PRES. SYST
FDA 510(k) clearance K921048 · decided 1993-07-01
Clearance details
- K-number
- K921048
- Device name
- BP8800T/8000IR/8300G NON-INVASIVE BLOOD PRES. SYST
- Applicant
- Colin Medical Instruments Corp.
- Decision
- Substantially Equivalent
- Date received
- 1992-03-04
- Decision date
- 1993-07-01
- Days to decision
- 484 days
- Clearance type
- Traditional
- Product code
- DXN
- Device class
- 2
- Regulation number
- 870.1130
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- San Antonio, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.