MADETT
FDA 510(k) clearance K021044 · decided 2002-09-11
Clearance details
- K-number
- K021044
- Device name
- MADETT
- Applicant
- Wolfe Tory Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-04-01
- Decision date
- 2002-09-11
- Days to decision
- 163 days
- Clearance type
- Traditional
- Product code
- BTR
- Device class
- 2
- Regulation number
- 868.5730
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Salt Lake City, UT, US
- Third-party review
- No
- Expedited review
- No
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