The following data is part of a premarket notification filed by Vapotherm, Inc. with the FDA for Precision Flow(r) - Heliox.
| Device ID | K111640 |
| 510k Number | K111640 |
| Device Name: | PRECISION FLOW(R) - HELIOX |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | VAPOTHERM, INC. 198 Log Canoe Circle Stevensville, MD 21666 |
| Contact | Gregory A Whitney |
| Correspondent | Gregory A Whitney VAPOTHERM, INC. 198 Log Canoe Circle Stevensville, MD 21666 |
| Product Code | BTT |
| CFR Regulation Number | 868.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-13 |
| Decision Date | 2011-10-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841737101352 | K111640 | 000 |