The following data is part of a premarket notification filed by Salter Labs, Arvin Facility with the FDA for Salter Labs Bubble Humidifier (high Flow).
| Device ID | K113542 |
| 510k Number | K113542 |
| Device Name: | SALTER LABS BUBBLE HUMIDIFIER (HIGH FLOW) |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | SALTER LABS, ARVIN FACILITY 100 Sycamore Rd Arvin, CA 93203 |
| Contact | Michael Shoup |
| Correspondent | Casey Conry UNDERWRITERS LABORATORIES, INC. 1285 WALT WHITMAN RD. Melville, NY 11747 |
| Product Code | BTT |
| CFR Regulation Number | 868.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2011-12-01 |
| Decision Date | 2012-02-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10607411940689 | K113542 | 000 |
| 10607411009430 | K113542 | 000 |
| 10607411102063 | K113542 | 000 |
| 10607411102087 | K113542 | 000 |
| 20607411700051 | K113542 | 000 |
| 10607411700085 | K113542 | 000 |
| 10607411893480 | K113542 | 000 |
| 10607411915939 | K113542 | 000 |
| 10607411915946 | K113542 | 000 |
| 10607411915953 | K113542 | 000 |
| 10607411918534 | K113542 | 000 |
| 00607411000898 | K113542 | 000 |