510(k) K913501
K913501 is an FDA 510(k) premarket notification submitted by B & F Medical Products, Inc. for the device "TRACHEOSTOMY MASK". The FDA issued a decision of Substantially Equivalent on January 13, 1992. 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 13, 1992
- Date Received
- August 7, 1991
- 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