The following data is part of a premarket notification filed by Vitalograph Ltd. with the FDA for Dual-aid.
| Device ID | K860949 |
| 510k Number | K860949 |
| Device Name: | DUAL-AID |
| Classification | Airway, Oropharyngeal, Anesthesiology |
| Applicant | VITALOGRAPH LTD. 8347 QUIVIRA RD. Lenexa, KS 66215 |
| Contact | Lovina G Freeman |
| Correspondent | Lovina G Freeman VITALOGRAPH LTD. 8347 QUIVIRA RD. Lenexa, KS 66215 |
| Product Code | CAE |
| CFR Regulation Number | 868.5110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-12 |
| Decision Date | 1986-05-06 |