AM1000
FDA 510(k) clearance K864590 · decided 1987-05-04
Clearance details
- K-number
- K864590
- Device name
- AM1000
- Applicant
- Bear Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-11-21
- Decision date
- 1987-05-04
- Days to decision
- 164 days
- Clearance type
- Traditional
- Product code
- BSZ
- Device class
- 2
- Regulation number
- 868.5160
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Riverside, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.