MODEL 215M PATIENT SIMULATOR
FDA 510(k) clearance K897074 · decided 1990-05-17
Clearance details
- K-number
- K897074
- Device name
- MODEL 215M PATIENT SIMULATOR
- Applicant
- Dynatech/Nevada, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-12-22
- Decision date
- 1990-05-17
- Days to decision
- 146 days
- Clearance type
- Traditional
- Product code
- DSI
- Device class
- 2
- Regulation number
- 870.1025
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Carson City, NV, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.