The following data is part of a premarket notification filed by Meridian Medical Systems, Inc. with the FDA for Meridian Medical Systems Mapleson D And Modified Jackson Reese Circuits.
| Device ID | K945984 |
| 510k Number | K945984 |
| Device Name: | MERIDIAN MEDICAL SYSTEMS MAPLESON D AND MODIFIED JACKSON REESE CIRCUITS |
| Classification | Circuit, Breathing (w Connector, Adaptor, Y Piece) |
| Applicant | MERIDIAN MEDICAL SYSTEMS, INC. 8102 WOOD LAND DR. Indianapolis, IN 46278 |
| Contact | Robert Richmond |
| Correspondent | Robert Richmond MERIDIAN MEDICAL SYSTEMS, INC. 8102 WOOD LAND DR. Indianapolis, IN 46278 |
| Product Code | CAI |
| CFR Regulation Number | 868.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-08 |
| Decision Date | 1994-12-27 |