Submission Details
| 510(k) Number | K961894 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 16, 1996 |
| Decision Date | August 14, 1996 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
Cleared
Traditional
MDI TUTOR
Aug 1996
Decision
90d
Days
Class 1
Risk
About This 510(k) Submission
K961894 is an FDA 510(k) clearance for the MDI TUTOR, a Nebulizer, Medicinal, Non-ventilatory (atomizer) (Class I — General Controls, product code CCQ), submitted by Mdi Tutor, Inc. (North Attleboro, US). The FDA issued a Cleared decision on August 14, 1996, 90 days after receiving the submission on May 16, 1996. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5640.
Device Classification
| Product Code | CCQ — Nebulizer, Medicinal, Non-ventilatory (atomizer) |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 868.5640 |
Manufacturer
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