The following data is part of a premarket notification filed by Vital Signs, Inc. with the FDA for 7cm Berman Airway.
| Device ID | K820512 |
| 510k Number | K820512 |
| Device Name: | 7CM BERMAN AIRWAY |
| Classification | Airway, Oropharyngeal, Anesthesiology |
| Applicant | VITAL SIGNS, INC. 1 MADISON ST. East Rutherford, NJ 07073 |
| Contact | Kerry J Savage |
| Correspondent | Kerry J Savage VITAL SIGNS, INC. 1 MADISON ST. East Rutherford, NJ 07073 |
| Product Code | CAE |
| CFR Regulation Number | 868.5110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-02-25 |
| Decision Date | 1982-03-26 |