EMI THERAPY SIMULATOR
FDA 510(k) clearance K771817 · decided 1978-01-13
Clearance details
- K-number
- K771817
- Device name
- EMI THERAPY SIMULATOR
- Applicant
- Emi Therapy Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1977-09-26
- Decision date
- 1978-01-13
- Days to decision
- 109 days
- Clearance type
- Traditional
- Product code
- JAD
- Device class
- 2
- Regulation number
- 892.5900
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.