510(k) K781039
K781039 is an FDA 510(k) premarket notification submitted by Chambers & Sadler Mfg. for the device "OXY-ON DIGITAL OXYGEN TIMER". The FDA issued a decision of Substantially Equivalent on August 31, 1978. The device falls under product code BXP (Transducer, Gas Flow), a Class I device regulated under 21 CFR 868.2885.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 31, 1978
- Date Received
- June 19, 1978
- 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