TRANSTHORACIC TEMP. PACEMAKER #100TPE
FDA 510(k) clearance K820232 · decided 1982-04-09
Clearance details
- K-number
- K820232
- Device name
- TRANSTHORACIC TEMP. PACEMAKER #100TPE
- Applicant
- Trans Pace, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-01-28
- Decision date
- 1982-04-09
- Days to decision
- 71 days
- Clearance type
- Traditional
- Product code
- LDF
- Device class
- 2
- Regulation number
- 870.3680
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.