510(k) K885079
K885079 is an FDA 510(k) premarket notification submitted by Mennen Medical, Inc. for the device "HORIZON 2000 TRANSCUTANEOUS GAS #26X-OPT-275". The FDA issued a decision of Substantially Equivalent on February 17, 1989. The device falls under product code LPP (Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia), a Class II device regulated under 21 CFR 868.2500. Mennen Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 17, 1989
- Date Received
- December 8, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia
- Device Class
- Class II
- Regulation Number
- 868.2500
- Review Panel
- AN
- Submission Type