Submission Details
| 510(k) Number | K021634 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 17, 2002 |
| Decision Date | January 09, 2003 |
| Days to Decision | 237 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
Cleared
Traditional
KING LT, MODELS # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 105
Jan 2003
Decision
237d
Days
Class 1
Risk
About This 510(k) Submission
K021634 is an FDA 510(k) clearance for the KING LT, MODELS # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 105, a Airway, Oropharyngeal, Anesthesiology (Class I — General Controls, product code CAE), submitted by King Systems Corp. (Noblesville, US). The FDA issued a Cleared decision on January 9, 2003, 237 days after receiving the submission on May 17, 2002. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5110.
Device Classification
| Product Code | CAE — Airway, Oropharyngeal, Anesthesiology |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 868.5110 |
Manufacturer
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