BEEHIVE-64 OR BEEHIVE-32, DIGITAL EEG RECORDING
FDA 510(k) clearance K884937 · decided 1989-04-14
Clearance details
- K-number
- K884937
- Device name
- BEEHIVE-64 OR BEEHIVE-32, DIGITAL EEG RECORDING
- Applicant
- Grass-Telefactor Product Group
- Decision
- Substantially Equivalent
- Date received
- 1988-11-28
- Decision date
- 1989-04-14
- Days to decision
- 137 days
- Clearance type
- Traditional
- Product code
- EEG
- Device class
- 1
- Regulation number
- 872.6475
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- W. Conshohocken, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.