The following data is part of a premarket notification filed by Kontron Instruments, Inc. with the FDA for Kontron Cutaneous Po2 Monitor 820.
| Device ID | K860951 |
| 510k Number | K860951 |
| Device Name: | KONTRON CUTANEOUS PO2 MONITOR 820 |
| Classification | Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia |
| Applicant | KONTRON INSTRUMENTS, INC. 9 PLYMOUTH ST. Everett, MA 02149 |
| Contact | George Cho |
| Correspondent | George Cho KONTRON INSTRUMENTS, INC. 9 PLYMOUTH ST. Everett, MA 02149 |
| Product Code | KLK |
| CFR Regulation Number | 868.2500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-12 |
| Decision Date | 1986-04-09 |