510(k) K955483
K955483 is an FDA 510(k) premarket notification submitted by Hospitak, Inc. for the device "TRACH MASK MODEL (245, 246)". The FDA issued a decision of Substantially Equivalent on February 28, 1996. The device falls under product code BYF (Mask, Oxygen, Low Concentration, Venturi), a Class I device regulated under 21 CFR 868.5600. Hospitak, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 28, 1996
- Date Received
- December 1, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mask, Oxygen, Low Concentration, Venturi
- Device Class
- Class I
- Regulation Number
- 868.5600
- Review Panel
- AN
- Submission Type