RESPONDER 3000
FDA 510(k) clearance K000638 · decided 2000-10-30
Clearance details
- K-number
- K000638
- Device name
- RESPONDER 3000
- Applicant
- Ge Medical Systems Information Technologies GmbH
- Decision
- Substantially Equivalent
- Date received
- 2000-02-25
- Decision date
- 2000-10-30
- Days to decision
- 248 days
- Clearance type
- Traditional
- Product code
- MKJ
- Device class
- 3
- Regulation number
- 870.5310
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Freiburg, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.