REEVUE INDIRECT CALORIMETER, MODEL#8100
FDA 510(k) clearance K021490 · decided 2003-01-02
Clearance details
- K-number
- K021490
- Device name
- REEVUE INDIRECT CALORIMETER, MODEL#8100
- Applicant
- Korr Medical Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-05-09
- Decision date
- 2003-01-02
- Days to decision
- 238 days
- Clearance type
- Traditional
- Product code
- BZL
- Device class
- 2
- Regulation number
- 868.1730
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Salt Lake City, UT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.