EK COMBI MSG-1
FDA 510(k) clearance K830410 · decided 1983-04-27
Clearance details
- K-number
- K830410
- Device name
- EK COMBI MSG-1
- Applicant
- Jedmed Instrument Co.
- Decision
- Substantially Equivalent
- Date received
- 1983-02-08
- Decision date
- 1983-04-27
- Days to decision
- 78 days
- Clearance type
- Traditional
- Product code
- DSP
- Device class
- 2
- Regulation number
- 870.3535
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.