PACEMAKER, PROLITH 23U. PULSE GENERATOR
FDA 510(k) clearance K780238 · decided 1978-03-15
Clearance details
- K-number
- K780238
- Device name
- PACEMAKER, PROLITH 23U. PULSE GENERATOR
- Applicant
- Edwards Pacemaker Systems
- Decision
- Substantially Equivalent
- Date received
- 1978-02-13
- Decision date
- 1978-03-15
- Days to decision
- 30 days
- Clearance type
- Traditional
- Product code
- DXY
- Device class
- 3
- Regulation number
- 870.3610
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Edwards Pacemaker Systems
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.