Perimed Transcutaneous PO2 and PCO2 Monitor (PF5040)
FDA 510(k) K990960 · Perimed, Inc.
510(k) numberK990960
Submission
- Device name
- Perimed Transcutaneous PO2 and PCO2 Monitor (PF5040)
- Applicant
- Perimed, Inc.
Laurel, MD, US - Received
- March 22, 1999
- Decision date
- September 23, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LKD – Monitor, Carbon-Dioxide, Cutaneous
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.2480
- Specialty
- Anesthesiology
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Questions and answers
When was Perimed Transcutaneous PO2 and PCO2 Monitor (PF5040) cleared by the FDA?
Perimed Transcutaneous PO2 and PCO2 Monitor (PF5040) (K990960) received a 510(k) decision of Substantially Equivalent on September 23, 1999, 185 days after the submission was received.
What is the product code of K990960?
The FDA product code is LKD – Monitor, Carbon-Dioxide, Cutaneous, a Class II (moderate risk) device regulated under 21 CFR 868.2480.