The following data is part of a premarket notification filed by Flexicare Medical Ltd. with the FDA for Flexicare Heated Wire Breathing Systems.
| Device ID | K150900 |
| 510k Number | K150900 |
| Device Name: | Flexicare Heated Wire Breathing Systems |
| Classification | Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer |
| Applicant | FLEXICARE MEDICAL LTD. CYNON VALLEY BUSINESS PARK MOUNTAIN ASH Mid Glamorgan, GB Cf45 4er |
| Contact | Joel Biddle |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | BZE |
| CFR Regulation Number | 868.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2015-04-03 |
| Decision Date | 2015-05-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055788771050 | K150900 | 000 |
| 05055788708650 | K150900 | 000 |
| 05055788708643 | K150900 | 000 |
| 05055788708636 | K150900 | 000 |
| 05055788708629 | K150900 | 000 |
| 05055788708612 | K150900 | 000 |
| 05055788708605 | K150900 | 000 |
| 05055788708599 | K150900 | 000 |
| 05055788711940 | K150900 | 000 |
| 05055788708582 | K150900 | 000 |
| 05055788708575 | K150900 | 000 |
| 05055788708667 | K150900 | 000 |
| 05055788708674 | K150900 | 000 |
| 05055788708681 | K150900 | 000 |
| 05055788771036 | K150900 | 000 |
| 05055788769996 | K150900 | 000 |
| 05055788769989 | K150900 | 000 |
| 05055788711964 | K150900 | 000 |
| 05055788711957 | K150900 | 000 |
| 05055788709664 | K150900 | 000 |
| 05055788709657 | K150900 | 000 |
| 05055788709626 | K150900 | 000 |
| 05055788709619 | K150900 | 000 |
| 05055788708698 | K150900 | 000 |
| 05055931103783 | K150900 | 000 |