MOD. 587 BLOOD PRESSURE & PULSE MONITOR
FDA 510(k) clearance K813556 · decided 1982-01-22
Clearance details
- K-number
- K813556
- Device name
- MOD. 587 BLOOD PRESSURE & PULSE MONITOR
- Applicant
- Bio Mega Diagnostic, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-12-22
- Decision date
- 1982-01-22
- Days to decision
- 31 days
- Clearance type
- Traditional
- Product code
- DXN
- Device class
- 2
- Regulation number
- 870.1130
- 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.