POLY G PHYSIOLOGICAL DATA RECORDER— 510(k) K897107
Substantially EquivalentCns, Inc.
FDA 510(k) clearance K897107 for POLY G PHYSIOLOGICAL DATA RECORDER, Substantially Equivalent on 1990-03-12. Applicant: Cns, Inc.. Device class: 1.
Clearance details
- Applicant
- Cns, Inc.
- Product code
- Code BXO
- Device class
- Class 1
- Regulation
- 21 CFR 868.2900
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Eden Prairie, MN, US
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