The following data is part of a premarket notification filed by Sumitomo Electric Industries, Inc. with the FDA for Po-510 Tcpo2 Monitor.
| Device ID | K852959 |
| 510k Number | K852959 |
| Device Name: | PO-510 TCPO2 MONITOR |
| Classification | Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia |
| Applicant | SUMITOMO ELECTRIC INDUSTRIES, INC. 1-3 SHIMAYA 1-CHOME KONOHANA-KU Osaka, 554 Japan, JP |
| Contact | Kunihiko Taniguchi |
| Correspondent | Kunihiko Taniguchi SUMITOMO ELECTRIC INDUSTRIES, INC. 1-3 SHIMAYA 1-CHOME KONOHANA-KU Osaka, 554 Japan, JP |
| Product Code | KLK |
| CFR Regulation Number | 868.2500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-12 |
| Decision Date | 1985-11-29 |