510(k) K884614
K884614 is an FDA 510(k) premarket notification submitted by Edentec Corp. for the device "EDENTEC MODEL 2000W OPTION S CARDIO-RESP. PROCESS.". The FDA issued a decision of Substantially Equivalent on February 1, 1989. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Edentec Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 1, 1989
- Date Received
- November 4, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Oximeter
- Device Class
- Class II
- Regulation Number
- 870.2700
- Review Panel
- AN
- Submission Type