510(k) K823532
K823532 is an FDA 510(k) premarket notification submitted by B & F Medical Products, Inc. for the device "STOCK #64091-PEDIATRIC OXYGEN MASK". The FDA issued a decision of Substantially Equivalent on January 5, 1983. The device falls under product code BYG (Mask, Oxygen), a Class I device regulated under 21 CFR 868.5580. B & F Medical Products, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 5, 1983
- Date Received
- November 29, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mask, Oxygen
- Device Class
- Class I
- Regulation Number
- 868.5580
- Review Panel
- AN
- Submission Type