The following data is part of a premarket notification filed by Ackrad Laboratories with the FDA for N-doguide(tm) Endotracheal Tube Introducing Guide.
| Device ID | K865108 |
| 510k Number | K865108 |
| Device Name: | N-DOGUIDE(TM) ENDOTRACHEAL TUBE INTRODUCING GUIDE |
| Classification | Stylet, Tracheal Tube |
| Applicant | ACKRAD LABORATORIES 70 JACKSON DR. Cranford, NJ 07016 |
| Contact | Ackerman, Md |
| Correspondent | Ackerman, Md ACKRAD LABORATORIES 70 JACKSON DR. Cranford, NJ 07016 |
| Product Code | BSR |
| CFR Regulation Number | 868.5790 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-31 |
| Decision Date | 1987-02-10 |