510(k) K001866
K001866 is an FDA 510(k) premarket notification submitted by Radiometer Medical A/S for the device "TCM400". The FDA issued a decision of Substantially Equivalent on December 7, 2000. 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. Radiometer Medical A/S has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 7, 2000
- Date Received
- June 20, 2000
- Clearance Type
- Special
- 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