The following data is part of a premarket notification filed by Intersurgical, Inc. with the FDA for Disposable Gas Sampling Line With And Without In-line Filter.
| Device ID | K122075 |
| 510k Number | K122075 |
| Device Name: | DISPOSABLE GAS SAMPLING LINE WITH AND WITHOUT IN-LINE FILTER |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | INTERSURGICAL, INC. 417 ELECTRONICS PKWY. Liverpool, NY 13088 |
| Contact | Michael Zaleewski |
| Correspondent | Michael Zaleewski INTERSURGICAL, INC. 417 ELECTRONICS PKWY. Liverpool, NY 13088 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-16 |
| Decision Date | 2012-12-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05030267011797 | K122075 | 000 |
| 05030267159413 | K122075 | 000 |
| 05030267159833 | K122075 | 000 |
| 05030267159819 | K122075 | 000 |
| 05030267159796 | K122075 | 000 |
| 05030267044221 | K122075 | 000 |
| 05030267163540 | K122075 | 000 |
| 05030267011674 | K122075 | 000 |
| 05030267011872 | K122075 | 000 |