The following data is part of a premarket notification filed by Intersurgical, Inc. with the FDA for Intersurgical Heated Wire Breathing Systems And Humidification Chambers, Model 2026,2026-ch, 2310, 2320, 2330.
| Device ID | K092129 |
| 510k Number | K092129 |
| Device Name: | INTERSURGICAL HEATED WIRE BREATHING SYSTEMS AND HUMIDIFICATION CHAMBERS, MODEL 2026,2026-CH, 2310, 2320, 2330 |
| Classification | Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer |
| Applicant | INTERSURGICAL, INC. 417 ELECTRONICS PKWY. Liverpool, NY 13088 |
| Contact | Michael Zalewski |
| Correspondent | Michael Zalewski INTERSURGICAL, INC. 417 ELECTRONICS PKWY. Liverpool, NY 13088 |
| Product Code | BZE |
| CFR Regulation Number | 868.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-15 |
| Decision Date | 2010-05-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05030267151561 | K092129 | 000 |
| 05030267151530 | K092129 | 000 |
| 05030267140350 | K092129 | 000 |
| 05030267140336 | K092129 | 000 |
| 05030267096336 | K092129 | 000 |
| 05030267106981 | K092129 | 000 |
| 05030267095865 | K092129 | 000 |
| 05030267095841 | K092129 | 000 |
| 05030267095827 | K092129 | 000 |