PHONATORY FUNCTION ANALYZER PS-77— 510(k) K832678
Substantially EquivalentKells Medical, Inc.
FDA 510(k) clearance K832678 for PHONATORY FUNCTION ANALYZER PS-77, Substantially Equivalent on 1984-03-07. Applicant: Kells Medical, Inc.. Device class: 1.
Clearance details
- Applicant
- Kells Medical, Inc.
- Product code
- Code BXP
- Device class
- Class 1
- Regulation
- 21 CFR 868.2885
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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