The following data is part of a premarket notification filed by Teleflex Medical , Inc. with the FDA for Hudson Rci Aquapak Humidifier Adaptor.
| Device ID | K141353 |
| 510k Number | K141353 |
| Device Name: | HUDSON RCI AQUAPAK HUMIDIFIER ADAPTOR |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | TELEFLEX MEDICAL , INC. 2917 WEEK DRIVE Research Triangle Park, NC 27709 |
| Contact | James A Cochie |
| Correspondent | James A Cochie TELEFLEX MEDICAL , INC. 2917 WEEK DRIVE Research Triangle Park, NC 27709 |
| Product Code | BTT |
| CFR Regulation Number | 868.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-23 |
| Decision Date | 2014-08-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 34026704627678 | K141353 | 000 |
| 20197344007476 | K141353 | 000 |
| 24026704391855 | K141353 | 000 |
| 24026704597028 | K141353 | 000 |
| 24026704597066 | K141353 | 000 |
| 24026704597080 | K141353 | 000 |
| 34026704611349 | K141353 | 000 |
| 34026704627500 | K141353 | 000 |
| 34026704627548 | K141353 | 000 |
| 34026704627654 | K141353 | 000 |
| 20193489138471 | K141353 | 000 |