The following data is part of a premarket notification filed by Ambu, Inc. with the FDA for Ambu Tubecheck.
| Device ID | K981891 |
| 510k Number | K981891 |
| Device Name: | AMBU TUBECHECK |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | AMBU, INC. 611 NORTH HAMMONDS FERRY RD. Linthicum, MD 21090 -1356 |
| Contact | Sanjay H Parikh |
| Correspondent | Sanjay H Parikh AMBU, INC. 611 NORTH HAMMONDS FERRY RD. Linthicum, MD 21090 -1356 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-29 |
| Decision Date | 1998-07-17 |