The following data is part of a premarket notification filed by Mallinckrodt Dar S.r.l. with the FDA for Mallinckrodt Dar Heated Wire Breathing Circuit.
| Device ID | K993268 |
| 510k Number | K993268 |
| Device Name: | MALLINCKRODT DAR HEATED WIRE BREATHING CIRCUIT |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | MALLINCKRODT DAR S.R.L. VIA G.BOVE, 2/4/6/8 Mirandola (modena), IT 41037 |
| Contact | Giuseppe Tomasini |
| Correspondent | Giuseppe Tomasini MALLINCKRODT DAR S.R.L. VIA G.BOVE, 2/4/6/8 Mirandola (modena), IT 41037 |
| Product Code | BTT |
| CFR Regulation Number | 868.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-30 |
| Decision Date | 2000-04-19 |
| Summary: | summary |