BIO-LOG 8+1 AMBULATORY PHYSIOLOGIC RECORDER— 510(k) K864928
Substantially EquivalentBio-Scan, Inc.
FDA 510(k) clearance K864928 for BIO-LOG 8+1 AMBULATORY PHYSIOLOGIC RECORDER, Substantially Equivalent on 1987-03-31. Applicant: Bio-Scan, Inc.. Device class: 2.
Clearance details
- Applicant
- Bio-Scan, Inc.
- Product code
- Code GWQ
- Device class
- Class 2
- Regulation
- 21 CFR 882.1400
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dallas, TX, US
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