The following data is part of a premarket notification filed by Flexicare Medical Ltd. with the FDA for Ventimask Mk Iv.
| Device ID | K951652 |
| 510k Number | K951652 |
| Device Name: | VENTIMASK MK IV |
| Classification | Mask, Oxygen, Low Concentration, Venturi |
| Applicant | FLEXICARE MEDICAL LTD. EAST QUAY, BRIDGWATER Somerset, GB Ta64db |
| Contact | Colin Beckett |
| Correspondent | Colin Beckett FLEXICARE MEDICAL LTD. EAST QUAY, BRIDGWATER Somerset, GB Ta64db |
| Product Code | BYF |
| CFR Regulation Number | 868.5600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-10 |
| Decision Date | 1995-04-27 |