PACEVIEW
FDA 510(k) clearance K915627 · decided 1992-03-27
Clearance details
- K-number
- K915627
- Device name
- PACEVIEW
- Applicant
- Micromedical Industries, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1991-12-09
- Decision date
- 1992-03-27
- Days to decision
- 109 days
- Clearance type
- Traditional
- Product code
- KRB
- Device class
- 2
- Regulation number
- 870.1915
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Northbrook, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.