The following data is part of a premarket notification filed by Laerdal Medical Corp. with the FDA for Trachlight Stylet & Tracheal Lightwand (original Application Name: Stylett & Tracheal Lightwand).
| Device ID | K954771 |
| 510k Number | K954771 |
| Device Name: | TRACHLIGHT STYLET & TRACHEAL LIGHTWAND (ORIGINAL APPLICATION NAME: STYLETT & TRACHEAL LIGHTWAND) |
| Classification | Stylet, Tracheal Tube |
| Applicant | LAERDAL MEDICAL CORP. 167 MYERS CORNERS RD. P.O. BOX 1840 Wappingers Falls, NY 12590 -8840 |
| Contact | Ken Herland |
| Correspondent | Ken Herland LAERDAL MEDICAL CORP. 167 MYERS CORNERS RD. P.O. BOX 1840 Wappingers Falls, NY 12590 -8840 |
| Product Code | BSR |
| CFR Regulation Number | 868.5790 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-17 |
| Decision Date | 1996-05-09 |
| Summary: | summary |