The following data is part of a premarket notification filed by Medelec Ltd. with the FDA for Arc.
| Device ID | K934669 |
| 510k Number | K934669 |
| Device Name: | ARC |
| Classification | Gas-machine, Anesthesia |
| Applicant | MEDELEC LTD. MANOR WAY OLD WOKING Surrey, England Gu22 9ju, GB |
| Contact | J B Holloway |
| Correspondent | J B Holloway MEDELEC LTD. MANOR WAY OLD WOKING Surrey, England Gu22 9ju, GB |
| Product Code | BSZ |
| CFR Regulation Number | 868.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-29 |
| Decision Date | 1994-04-26 |