FEEDBACK EDR SYSTEM MODEL EDR-100
FDA 510(k) clearance K770790 · decided 1977-05-10
Clearance details
- K-number
- K770790
- Device name
- FEEDBACK EDR SYSTEM MODEL EDR-100
- Applicant
- Bio-Feedback Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1977-05-02
- Decision date
- 1977-05-10
- Days to decision
- 8 days
- Clearance type
- Traditional
- Product code
- HCC
- Device class
- 2
- Regulation number
- 882.5050
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- 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.