510(k) K813188
K813188 is an FDA 510(k) premarket notification submitted by Montrose Phototherapy Supply for the device "INFANT PHOTOTHERAPY LIGHT". The FDA issued a decision of Substantially Equivalent on December 9, 1981. The device falls under product code LBI (Unit, Neonatal Phototherapy), a Class II device regulated under 21 CFR 880.5700. 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 16, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, Neonatal Phototherapy
- Device Class
- Class II
- Regulation Number
- 880.5700
- Review Panel
- HO
- Submission Type