510(k) K882291
K882291 is an FDA 510(k) premarket notification submitted by Physician Engineered Products, Inc. for the device "RETROFIT BABY FACE SHIELD (RFS)". The FDA issued a decision of Substantially Equivalent on June 20, 1988. The device falls under product code LBI (Unit, Neonatal Phototherapy), a Class II device regulated under 21 CFR 880.5700. Physician Engineered Products, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 20, 1988
- Date Received
- June 1, 1988
- 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