The following data is part of a premarket notification filed by Flexicare Medical Limited with the FDA for Thermoshield Hme Filter.
| Device ID | K163300 |
| 510k Number | K163300 |
| Device Name: | ThermoShield HME Filter |
| Classification | Filter, Bacterial, Breathing-circuit |
| 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 | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2016-11-22 |
| Decision Date | 2017-03-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055788777199 | K163300 | 000 |
| 05055788770213 | K163300 | 000 |
| 05055788770183 | K163300 | 000 |
| 05055788770176 | K163300 | 000 |
| 05055788770169 | K163300 | 000 |
| 05055788770152 | K163300 | 000 |
| 05055788770145 | K163300 | 000 |
| 05055788742470 | K163300 | 000 |
| 05055788742036 | K163300 | 000 |
| 05055788741145 | K163300 | 000 |
| 05055788770220 | K163300 | 000 |
| 05055788770244 | K163300 | 000 |
| 05055788777182 | K163300 | 000 |
| 05055788773511 | K163300 | 000 |
| 05055788773504 | K163300 | 000 |
| 05055788773474 | K163300 | 000 |
| 05055788772309 | K163300 | 000 |
| 05055788772248 | K163300 | 000 |
| 05055788772231 | K163300 | 000 |
| 05055788772224 | K163300 | 000 |
| 05055788771098 | K163300 | 000 |
| 05055788740902 | K163300 | 000 |