SM-20 CARDIOSCAN DOPPLER OPTION WITH CFM700 PROBES
FDA 510(k) clearance K863372 · decided 1986-11-04
Clearance details
- K-number
- K863372
- Device name
- SM-20 CARDIOSCAN DOPPLER OPTION WITH CFM700 PROBES
- Applicant
- Interspec, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-09-02
- Decision date
- 1986-11-04
- Days to decision
- 63 days
- Clearance type
- Traditional
- Product code
- DPT
- Device class
- 2
- Regulation number
- 870.2120
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Conshohocken, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.