The following data is part of a premarket notification filed by Eme (electro Medical Equipment) Ltd. with the FDA for Infant Flow System, Model M672p.
| Device ID | K011516 |
| 510k Number | K011516 |
| Device Name: | INFANT FLOW SYSTEM, MODEL M672P |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | EME (ELECTRO MEDICAL EQUIPMENT) LTD. 60 GLADSTONE PLACE Brighton, Sussex, GB Bn2 3qd |
| Contact | Stuart Corner |
| Correspondent | Stuart Corner EME (ELECTRO MEDICAL EQUIPMENT) LTD. 60 GLADSTONE PLACE Brighton, Sussex, GB Bn2 3qd |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-17 |
| Decision Date | 2001-06-08 |