SENSOR TAPE CAT. NO. ST-45— 510(k) K852407
Substantially EquivalentAmerican Omni Medical, Inc.
FDA 510(k) clearance K852407 for SENSOR TAPE CAT. NO. ST-45, Substantially Equivalent on 1985-10-21. Applicant: American Omni Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- American Omni Medical, Inc.
- Product code
- Code DTW
- Device class
- Class 2
- Regulation
- 21 CFR 870.4340
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Costa Mesa, CA, US
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