SECHRIST AIR/OXYGEN MIXER, MODEL 3500 CP-G
FDA 510(k) clearance K023745 · decided 2003-01-17
Clearance details
- K-number
- K023745
- Device name
- SECHRIST AIR/OXYGEN MIXER, MODEL 3500 CP-G
- Applicant
- Sechrist Industries, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-11-07
- Decision date
- 2003-01-17
- Days to decision
- 71 days
- Clearance type
- Traditional
- Product code
- DTX
- Device class
- 2
- Regulation number
- 870.4300
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Anaheim, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.