MODEL 820 TOP=TRAK
FDA 510(k) clearance K873039 · decided 1988-02-11
Clearance details
- K-number
- K873039
- Device name
- MODEL 820 TOP=TRAK
- Applicant
- Sierra Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-08-04
- Decision date
- 1988-02-11
- Days to decision
- 191 days
- Clearance type
- Traditional
- Product code
- BYN
- Device class
- 1
- Regulation number
- 868.5365
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Carmel Valley, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.