510(k) K962361

TRACHLIGHT STYLET AND TRACHEAL LIGHTWAND by Laerdal Medical Corp. — Product Code BSR

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