ERGOTEST 40 & 45
FDA 510(k) clearance K843855 · decided 1984-11-27
Clearance details
- K-number
- K843855
- Device name
- ERGOTEST 40 & 45
- Applicant
- Erich Jaeger, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-10-01
- Decision date
- 1984-11-27
- Days to decision
- 57 days
- Clearance type
- Traditional
- Product code
- ISP
- Device class
- 1
- Regulation number
- 890.3420
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- 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.