510(k) K830253
K830253 is an FDA 510(k) premarket notification submitted by Andros Incorporated for the device "END TIDAL CO2 ANALYZER #411". The FDA issued a decision of Substantially Equivalent on Mar 31, 1983.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 31, 1983
- Date Received
- Jan 25, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No