510(k) K990960
K990960 is an FDA 510(k) premarket notification submitted by Perimed, Inc. for the device "PERIMED TRANSCUTANEOUS PO2 AND PCO2 MONITOR (PF5040)". The FDA issued a decision of Substantially Equivalent on September 23, 1999. The device falls under product code LKD (Monitor, Carbon-Dioxide, Cutaneous), a Class II device regulated under 21 CFR 868.2480. Perimed, Inc. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 23, 1999
- Date Received
- March 22, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Carbon-Dioxide, Cutaneous
- Device Class
- Class II
- Regulation Number
- 868.2480
- Review Panel
- AN
- Submission Type