AMS 3000M
FDA 510(k) clearance K936009 · decided 1995-05-03
Clearance details
- K-number
- K936009
- Device name
- AMS 3000M
- Applicant
- Acutronic Medical Systems AG
- Decision
- Substantially Equivalent
- Date received
- 1993-12-16
- Decision date
- 1995-05-03
- Days to decision
- 503 days
- Clearance type
- Traditional
- Product code
- CAP
- Device class
- 2
- Regulation number
- 868.2600
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Jona-Rapper Swril, CH
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.