510(k) K770424
K770424 is an FDA 510(k) premarket notification submitted by Timeter Instrument Corp. for the device "OXYGEN TWMER, MODEL SST". The FDA issued a decision of Substantially Equivalent on March 16, 1977. The device falls under product code BXP (Transducer, Gas Flow), a Class I device regulated under 21 CFR 868.2885. Timeter Instrument Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 16, 1977
- Date Received
- March 7, 1977
- 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