510(k) K881820
K881820 is an FDA 510(k) premarket notification submitted by Edentec Corp. for the device "EDENTEC MODEL 2800/2801 OXIMETER/PULSE OXIMETER". The FDA issued a decision of Substantially Equivalent on July 18, 1988. 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
- July 18, 1988
- Date Received
- April 29, 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