The following data is part of a premarket notification filed by Flexicare Medical Limited with the FDA for Flexicare Fl-9000u Respiratory Humidifier Base.
| Device ID | K161314 |
| 510k Number | K161314 |
| Device Name: | FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASE |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | FLEXICARE MEDICAL LIMITED CYNON VALLEY BUSINESS PARK Mountain Ash, GB Cf45 4er |
| Contact | Joel Biddle |
| Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren, NJ 07059 |
| Product Code | BTT |
| CFR Regulation Number | 868.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2016-05-11 |
| Decision Date | 2016-07-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055931112983 | K161314 | 000 |
| 05055931111009 | K161314 | 000 |