510(k) K962361
K962361 is an FDA 510(k) premarket notification submitted by Laerdal Medical Corp. for the device "TRACHLIGHT STYLET AND TRACHEAL LIGHTWAND". The FDA issued a decision of Substantially Equivalent on September 5, 1996. The device falls under product code BSR (Stylet, Tracheal Tube), a Class I device regulated under 21 CFR 868.5790. Laerdal Medical Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 5, 1996
- Date Received
- June 19, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stylet, Tracheal Tube
- Device Class
- Class I
- Regulation Number
- 868.5790
- Review Panel
- AN
- Submission Type