ERA 3000 PACING SYSTEM ANALYZER
FDA 510(k) clearance K042708 · decided 2004-10-20
Clearance details
- K-number
- K042708
- Device name
- ERA 3000 PACING SYSTEM ANALYZER
- Applicant
- Biotronik, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-09-30
- Decision date
- 2004-10-20
- Days to decision
- 20 days
- Clearance type
- Special
- Product code
- DTE
- Device class
- 2
- Regulation number
- 870.3600
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Lake Oswego, OR, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Biotronik
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.