510(k) K871603
K871603 is an FDA 510(k) premarket notification submitted by Timeter Instrument Corp. for the device "CRITERION II & IIA OXYGEN CONCENTRATORS". The FDA issued a decision of Substantially Equivalent on August 13, 1987. The device falls under product code CAW (Generator, Oxygen, Portable), a Class II device regulated under 21 CFR 868.5440. Timeter Instrument Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 13, 1987
- Date Received
- April 24, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Generator, Oxygen, Portable
- Device Class
- Class II
- Regulation Number
- 868.5440
- Review Panel
- AN
- Submission Type