OSCILLOMITT, MODELS CM 1050, CM 1040, CM 1030, CM 1020, CM 1010
FDA 510(k) clearance K000512 · decided 2000-09-26
Clearance details
- K-number
- K000512
- Device name
- OSCILLOMITT, MODELS CM 1050, CM 1040, CM 1030, CM 1020, CM 1010
- Applicant
- Cas Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-02-16
- Decision date
- 2000-09-26
- Days to decision
- 223 days
- Clearance type
- Traditional
- Product code
- DXQ
- Device class
- 2
- Regulation number
- 870.1120
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Branford, CT, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.