The following data is part of a premarket notification filed by Clement Clarke Intl., Ltd. with the FDA for Oneflow Fvc, Oneflow Fvc (kit), Oneflow Fvc Screen.
| Device ID | K042058 |
| 510k Number | K042058 |
| Device Name: | ONEFLOW FVC, ONEFLOW FVC (KIT), ONEFLOW FVC SCREEN |
| Classification | Spirometer, Diagnostic |
| Applicant | CLEMENT CLARKE INTL., LTD. EDINBURGH WAY Harlow, Essex, GB Cm20 2tt |
| Contact | Philip Hallybone |
| Correspondent | Philip Hallybone CLEMENT CLARKE INTL., LTD. EDINBURGH WAY Harlow, Essex, GB Cm20 2tt |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-30 |
| Decision Date | 2005-03-23 |
| Summary: | summary |