ELECTRODYNOGRAM SYSTEM
FDA 510(k) clearance K821255 · decided 1982-07-02
Clearance details
- K-number
- K821255
- Device name
- ELECTRODYNOGRAM SYSTEM
- Applicant
- The Langer Group
- Decision
- Substantially Equivalent
- Date received
- 1982-04-30
- Decision date
- 1982-07-02
- Days to decision
- 63 days
- Clearance type
- Traditional
- Product code
- KHX
- Device class
- 1
- Regulation number
- 890.1575
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- 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.