The following data is part of a premarket notification filed by Draeger Medical Systems, Inc. with the FDA for Infinity Cnap Smartpod.
| Device ID | K102968 |
| 510k Number | K102968 |
| Device Name: | INFINITY CNAP SMARTPOD |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | Draeger Medical Systems, Inc. 6 TECH DRIVE Andover, MA 01810 |
| Contact | Joyce Kilroy |
| Correspondent | Joyce Kilroy Draeger Medical Systems, Inc. 6 TECH DRIVE Andover, MA 01810 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-06 |
| Decision Date | 2011-02-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049098050685 | K102968 | 000 |
| 04049098005722 | K102968 | 000 |
| 04049098005715 | K102968 | 000 |
| 04049098005708 | K102968 | 000 |
| 04049098005692 | K102968 | 000 |
| 04049098004879 | K102968 | 000 |