BERA SH 221 BRIAN STEM AUDIOMETER
FDA 510(k) clearance K830173 · decided 1983-05-25
Clearance details
- K-number
- K830173
- Device name
- BERA SH 221 BRIAN STEM AUDIOMETER
- Applicant
- Jedmed Instrument Co.
- Decision
- Substantially Equivalent
- Date received
- 1983-01-18
- Decision date
- 1983-05-25
- Days to decision
- 127 days
- Clearance type
- Traditional
- Product code
- GNJ
- Device class
- 1
- Regulation number
- 866.3205
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- 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.