The following data is part of a premarket notification filed by Ambu, Inc. with the FDA for Ambu Ruben Circle Anesthesia System.
| Device ID | K844149 |
| 510k Number | K844149 |
| Device Name: | AMBU RUBEN CIRCLE ANESTHESIA SYSTEM |
| Classification | Circuit, Breathing (w Connector, Adaptor, Y Piece) |
| Applicant | AMBU, INC. 7 OLD SHERMAN TURNPIKE Danbury, CT 06810 |
| Contact | Andrea Moody |
| Correspondent | Andrea Moody AMBU, INC. 7 OLD SHERMAN TURNPIKE Danbury, CT 06810 |
| Product Code | CAI |
| CFR Regulation Number | 868.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-24 |
| Decision Date | 1984-11-15 |