The following data is part of a premarket notification filed by Vr Medical with the FDA for Vr Medical Heat And Moisture Exchanger And Filter.
| Device ID | K132709 |
| 510k Number | K132709 |
| Device Name: | VR MEDICAL HEAT AND MOISTURE EXCHANGER AND FILTER |
| Classification | Filter, Bacterial, Breathing-circuit |
| Applicant | VR MEDICAL 90 GAOXIN ROAD, ZHOUZHUANG Kun Shan, Jiangsu, CN 215325 |
| Contact | Lee Pan, Phd |
| Correspondent | Lee Pan, Phd VR MEDICAL 90 GAOXIN ROAD, ZHOUZHUANG Kun Shan, Jiangsu, CN 215325 |
| Product Code | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-29 |
| Decision Date | 2014-07-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16959180705513 | K132709 | 000 |
| 10850108006018 | K132709 | 000 |
| 00840117318083 | K132709 | 000 |
| 00840117305663 | K132709 | 000 |
| 00840117305403 | K132709 | 000 |
| 00840117305380 | K132709 | 000 |
| 00840117305366 | K132709 | 000 |
| 00840117305342 | K132709 | 000 |
| 00840117305328 | K132709 | 000 |
| 00840117305304 | K132709 | 000 |
| 00840117305281 | K132709 | 000 |
| 00369771001518 | K132709 | 000 |
| 10850108006025 | K132709 | 000 |
| 10850108006032 | K132709 | 000 |
| 10850108006094 | K132709 | 000 |
| 16959180704677 | K132709 | 000 |
| 16959180703892 | K132709 | 000 |
| 16959180703885 | K132709 | 000 |
| 16959180703878 | K132709 | 000 |
| 16959180703861 | K132709 | 000 |
| 16959180703854 | K132709 | 000 |
| 16959180703847 | K132709 | 000 |
| 16959180703830 | K132709 | 000 |
| 40888277361240 | K132709 | 000 |
| 30641043553743 | K132709 | 000 |
| 10850108006100 | K132709 | 000 |
| 20193489139997 | K132709 | 000 |