510(k) K920360
K920360 is an FDA 510(k) premarket notification submitted by Medical Fittings, Inc. for the device "TIMOX OXYGEN TIMER". The FDA issued a decision of Substantially Equivalent on August 3, 1992. The device falls under product code BXP (Transducer, Gas Flow), a Class I device regulated under 21 CFR 868.2885. Medical Fittings, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 3, 1992
- Date Received
- January 27, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Transducer, Gas Flow
- Device Class
- Class I
- Regulation Number
- 868.2885
- Review Panel
- AN
- Submission Type