The following data is part of a premarket notification filed by Spacelabs Healthcare with the FDA for Capnography Pad (92516).
| Device ID | K121017 |
| 510k Number | K121017 |
| Device Name: | CAPNOGRAPHY PAD (92516) |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | SPACELABS HEALTHCARE P.O. BOX 3018 Nederland, CO 80466 |
| Contact | Thomas Kroenke |
| Correspondent | Thomas Kroenke SPACELABS HEALTHCARE P.O. BOX 3018 Nederland, CO 80466 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-04 |
| Decision Date | 2012-07-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10841522108822 | K121017 | 000 |
| 10841522113086 | K121017 | 000 |