Submission Details
| 510(k) Number | K880682 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 19, 1988 |
| Decision Date | March 21, 1988 |
| Days to Decision | 31 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
Cleared
Traditional
MASK, ANESTH. INFLATABLE & PEDIATRIC SCENTED, DISP
Mar 1988
Decision
31d
Days
Class 1
Risk
About This 510(k) Submission
K880682 is an FDA 510(k) clearance for the MASK, ANESTH. INFLATABLE & PEDIATRIC SCENTED, DISP, a Mask, Gas, Anesthetic (Class I — General Controls, product code BSJ), submitted by King Systems Corp. (Noblesville, US). The FDA issued a Cleared decision on March 21, 1988, 31 days after receiving the submission on February 19, 1988. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5550.
Device Classification
| Product Code | BSJ — Mask, Gas, Anesthetic |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 868.5550 |
Manufacturer
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