PHOTOTHERAPY UNIT 7850 NEONATAL PHOTO— 510(k) K840454
Substantially EquivalentAir-Shields, Inc.
FDA 510(k) clearance K840454 for PHOTOTHERAPY UNIT 7850 NEONATAL PHOTO, Substantially Equivalent on 1984-03-23. Applicant: Air-Shields, Inc.. Device class: 2.
Clearance details
- Applicant
- Air-Shields, Inc.
- Product code
- Code LBI
- Device class
- Class 2
- Regulation
- 21 CFR 880.5700
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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