The following data is part of a premarket notification filed by Flexicare Medical Limited with the FDA for Flexicare Neonatal Heated Wire Breathing System.
| Device ID | K160540 |
| 510k Number | K160540 |
| Device Name: | FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM |
| Classification | Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer |
| Applicant | FLEXICARE MEDICAL LIMITED CYNON VALLEY BUSINESS PARK Mountain Ash, 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 | 2016-02-26 |
| Decision Date | 2016-06-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055788771081 | K160540 | 000 |
| 05055788708537 | K160540 | 000 |
| 05055788708544 | K160540 | 000 |
| 05055788708551 | K160540 | 000 |
| 05055788708568 | K160540 | 000 |
| 05055788770008 | K160540 | 000 |
| 05055788770015 | K160540 | 000 |
| 05055788770022 | K160540 | 000 |
| 05055788770039 | K160540 | 000 |
| 05055788770336 | K160540 | 000 |
| 05055788708520 | K160540 | 000 |