UNIVERSAL JET VENTILATOR MODEL AMS-1000
FDA 510(k) clearance K863155 · decided 1987-09-28
Clearance details
- K-number
- K863155
- Device name
- UNIVERSAL JET VENTILATOR MODEL AMS-1000
- Applicant
- Acutronic Medical Systems AG
- Decision
- Substantially Equivalent
- Date received
- 1986-08-15
- Decision date
- 1987-09-28
- Days to decision
- 409 days
- Clearance type
- Traditional
- Product code
- CBK
- Device class
- 2
- Regulation number
- 868.5895
- 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.