Submission Details
| 510(k) Number | K120079 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 10, 2012 |
| Decision Date | May 24, 2012 |
| Days to Decision | 135 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
Cleared
Traditional
PRIMED TRACHEOSTOMY TUBES (MULTIPLE)
May 2012
Decision
135d
Days
Class 2
Risk
About This 510(k) Submission
K120079 is an FDA 510(k) clearance for the PRIMED TRACHEOSTOMY TUBES (MULTIPLE), a Tube, Tracheostomy (w/wo Connector) (Class II — Special Controls, product code BTO), submitted by Primed Halberstadt Medizintechnik GmbH (Halberstadt, DE). The FDA issued a Cleared decision on May 24, 2012, 135 days after receiving the submission on January 10, 2012. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5800.
Device Classification
| Product Code | BTO — Tube, Tracheostomy (w/wo Connector) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 868.5800 |
Manufacturer
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