BRACKMANN EMG MONITORING SYSTEM
FDA 510(k) clearance K895838 · decided 1990-03-27
Clearance details
- K-number
- K895838
- Device name
- BRACKMANN EMG MONITORING SYSTEM
- Applicant
- Wr Medical Electronics Co.
- Decision
- Substantially Equivalent
- Date received
- 1989-10-02
- Decision date
- 1990-03-27
- Days to decision
- 176 days
- Clearance type
- Traditional
- Product code
- ETN
- Device class
- 2
- Regulation number
- 874.1820
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Stillwater, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.