The following data is part of a premarket notification filed by Intercontinental New Technologies, Inc. with the FDA for Frolov's Respiration Training Device, Frtd-01.
| Device ID | K992256 |
| 510k Number | K992256 |
| Device Name: | FROLOV'S RESPIRATION TRAINING DEVICE, FRTD-01 |
| Classification | Spirometer, Therapeutic (incentive) |
| Applicant | INTERCONTINENTAL NEW TECHNOLOGIES, INC. PO BOX 7007 Deerfield, IL 60015 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm INTERCONTINENTAL NEW TECHNOLOGIES, INC. PO BOX 7007 Deerfield, IL 60015 |
| Product Code | BWF |
| CFR Regulation Number | 868.5690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-06 |
| Decision Date | 2000-01-11 |
| Summary: | summary |