The following data is part of a premarket notification filed by Intersurgical Incorporated with the FDA for Exhalation Valve.
| Device ID | K132143 |
| 510k Number | K132143 |
| Device Name: | EXHALATION VALVE |
| Classification | Valve, Non-rebreathing |
| Applicant | INTERSURGICAL INCORPORATED 417 ELECTRONICS PARKWAY Liverpool, NY 13088 |
| Contact | Michael Zalewski |
| Correspondent | Michael Zalewski INTERSURGICAL INCORPORATED 417 ELECTRONICS PARKWAY Liverpool, NY 13088 |
| Product Code | CBP |
| CFR Regulation Number | 868.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-11 |
| Decision Date | 2014-06-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05030267117321 | K132143 | 000 |
| 05030267114252 | K132143 | 000 |
| 05030267120857 | K132143 | 000 |
| 05030267140855 | K132143 | 000 |
| 05030267140831 | K132143 | 000 |
| 05030267140817 | K132143 | 000 |
| 05030267045969 | K132143 | 000 |
| 05030267154050 | K132143 | 000 |
| 05030267040919 | K132143 | 000 |
| 05030267117994 | K132143 | 000 |
| 05030267114603 | K132143 | 000 |
| 05030267116232 | K132143 | 000 |
| 05030267117345 | K132143 | 000 |
| 05030267115150 | K132143 | 000 |
| 05030267115075 | K132143 | 000 |
| 05030267119110 | K132143 | 000 |
| 05030267114115 | K132143 | 000 |
| 05030267117178 | K132143 | 000 |
| 05030267118144 | K132143 | 000 |
| 05030267116218 | K132143 | 000 |
| 00816472023115 | K132143 | 000 |