END TIDAL CO2 ANALYZER #411
FDA 510(k) clearance K830253 · decided 1983-03-31
Clearance details
- K-number
- K830253
- Device name
- END TIDAL CO2 ANALYZER #411
- Applicant
- Andros Incorporated
- Decision
- Substantially Equivalent
- Date received
- 1983-01-25
- Decision date
- 1983-03-31
- Days to decision
- 65 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.