The following data is part of a premarket notification filed by Measurement Specialties, Inc. with the FDA for Finger And Ear Sensors And Neonatal-adult And Adult/pediatric Adhesive Sensors For Use With Nellcor R-cal Spo2.
| Device ID | K061191 |
| 510k Number | K061191 |
| Device Name: | FINGER AND EAR SENSORS AND NEONATAL-ADULT AND ADULT/PEDIATRIC ADHESIVE SENSORS FOR USE WITH NELLCOR R-CAL SPO2 |
| Classification | Oximeter |
| Applicant | MEASUREMENT SPECIALTIES, INC. 2300 MCDERMOTT ROAD # 200-207 Plano, TX 75025 |
| Contact | Krista Oakes |
| Correspondent | Krista Oakes MEASUREMENT SPECIALTIES, INC. 2300 MCDERMOTT ROAD # 200-207 Plano, TX 75025 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-28 |
| Decision Date | 2006-05-22 |
| Summary: | summary |