The following data is part of a premarket notification filed by S.p.o. Medical Equipment, Ltd. with the FDA for Pulseox 5500 Finger Device, Pulseox 7500 Wristwatch Device.
| Device ID | K040178 |
| 510k Number | K040178 |
| Device Name: | PULSEOX 5500 FINGER DEVICE, PULSEOX 7500 WRISTWATCH DEVICE |
| Classification | Oximeter |
| Applicant | S.P.O. MEDICAL EQUIPMENT, LTD. 20 HATA'AS STR; STE 213 BEIT HAPAMON (BOX 124) Kfar Saba, IL 44425 |
| Contact | Ahava Stein |
| Correspondent | Ahava Stein S.P.O. MEDICAL EQUIPMENT, LTD. 20 HATA'AS STR; STE 213 BEIT HAPAMON (BOX 124) Kfar Saba, IL 44425 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-01-26 |
| Decision Date | 2004-09-10 |
| Summary: | summary |