The following data is part of a premarket notification filed by Perimed, Inc. with the FDA for Perimed Transcutaneous Po2 And Pco2 Monitor (pf5040).
| Device ID | K990960 |
| 510k Number | K990960 |
| Device Name: | PERIMED TRANSCUTANEOUS PO2 AND PCO2 MONITOR (PF5040) |
| Classification | Monitor, Carbon-dioxide, Cutaneous |
| Applicant | PERIMED, INC. 14900 SWEITZER LN. Laurel, MD 20707 |
| Contact | James Howard |
| Correspondent | James Howard PERIMED, INC. 14900 SWEITZER LN. Laurel, MD 20707 |
| Product Code | LKD |
| CFR Regulation Number | 868.2480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-22 |
| Decision Date | 1999-09-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332834000264 | K990960 | 000 |
| 07332834000257 | K990960 | 000 |
| 07332834000240 | K990960 | 000 |