The following data is part of a premarket notification filed by King Systems Corp. with the FDA for King Lt, Models # Klt 100, Klt 101, Klt 102, Klt 103, Klt 104, Klt 105.
| Device ID | K021634 |
| 510k Number | K021634 |
| Device Name: | KING LT, MODELS # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 105 |
| Classification | Airway, Oropharyngeal, Anesthesiology |
| Applicant | KING SYSTEMS CORP. 15011 HERRIMAN BLVD. Noblesville, IN 46060 |
| Contact | Tom Mcgrail |
| Correspondent | Tom Mcgrail KING SYSTEMS CORP. 15011 HERRIMAN BLVD. Noblesville, IN 46060 |
| Product Code | CAE |
| CFR Regulation Number | 868.5110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-17 |
| Decision Date | 2003-01-09 |