510(k) K813214
K813214 is an FDA 510(k) premarket notification submitted by Montrose Phototherapy Supply for the device "INFANT PHOTOTHERAPY MASK". The FDA issued a decision of Substantially Equivalent on December 9, 1981. The device falls under product code FOK (Pad, Neonatal Eye), a Class I device regulated under 21 CFR 880.5270. Montrose Phototherapy Supply has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 9, 1981
- Date Received
- November 9, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pad, Neonatal Eye
- Device Class
- Class I
- Regulation Number
- 880.5270
- Review Panel
- HO
- Submission Type