The following data is part of a premarket notification filed by Covidien with the FDA for Bis Standard Sensor,1-channel (3 Electrodes); Bis Pedi Sensor,1-channel,3 Electrodes; Bis Quatro Sensor; Bis Pedi-xp Sensor,2-channel (4 Electrodes); Bis Extend Sensor; Bis Bilateral Sensor,4-channel (6 Elecrodes); Bis Insight Sensor,cvi-enabled,2-ch.
| Device ID | K143506 |
| 510k Number | K143506 |
| Device Name: | BIS STANDARD SENSOR,1-CHANNEL (3 ELECTRODES); BIS PEDI SENSOR,1-CHANNEL,3 ELECTRODES; BIS QUATRO SENSOR; BIS PEDI-XP SENSOR,2-CHANNEL (4 ELECTRODES); BIS EXTEND SENSOR; BIS BILATERAL SENSOR,4-CHANNEL (6 ELECRODES); BIS INSIGHT SENSOR,CVI-ENABLED,2-CH |
| Classification | Electrode, Cutaneous |
| Applicant | COVIDIEN 6135 GUNBARREL AVE Boulder, CO 80301 |
| Contact | Timothy Holwick |
| Correspondent | Timothy Holwick COVIDIEN 6135 GUNBARREL AVE Boulder, CO 80301 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-10 |
| Decision Date | 2015-04-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 90884521548387 | K143506 | 000 |