KONTRON CUTANEOUS PO2 MONITOR 820
FDA 510(k) clearance K860951 · decided 1986-04-09
Clearance details
- K-number
- K860951
- Device name
- KONTRON CUTANEOUS PO2 MONITOR 820
- Applicant
- Kontron Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-03-12
- Decision date
- 1986-04-09
- Days to decision
- 28 days
- Clearance type
- Traditional
- Product code
- KLK
- Device class
- 2
- Regulation number
- 868.2500
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Everett, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.