The following data is part of a premarket notification filed by Medical And Industrial Equipment with the FDA for Mie Falcon, Datex Engstrom Flexima Ii.
| Device ID | K971030 |
| 510k Number | K971030 |
| Device Name: | MIE FALCON, DATEX ENGSTROM FLEXIMA II |
| Classification | Gas-machine, Anesthesia |
| Applicant | MEDICAL AND INDUSTRIAL EQUIPMENT FALCON RD SOWTON INDUSTRIAL ESTATE Ex2 7na Exeter, GB |
| Contact | Henry Marshall |
| Correspondent | Henry Marshall MEDICAL AND INDUSTRIAL EQUIPMENT FALCON RD SOWTON INDUSTRIAL ESTATE Ex2 7na Exeter, GB |
| Product Code | BSZ |
| CFR Regulation Number | 868.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-20 |
| Decision Date | 1997-11-12 |