Flocap
FDA 510(k) K133540 · Maxtec, Inc.
510(k) numberK133540
Submission
- Device name
- Flocap
- Applicant
- Maxtec, Inc.
Salt Lake City, UT, US - Received
- November 18, 2013
- Decision date
- March 28, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1400
- Specialty
- Anesthesiology
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| K112402 | ULTRAMAXO2 Oxygen AnalyerCCL · Abbreviated | 12/14/2011SE |
| K063488 | MAXO2 CuCCL · Traditional | 02/22/2007SE |
| K040484 | MAXO2+, Model a and AeCCL · Traditional | 06/09/2004SE |
Questions and answers
When was Flocap cleared by the FDA?
Flocap (K133540) received a 510(k) decision of Substantially Equivalent on March 28, 2014, 130 days after the submission was received.
What is the product code of K133540?
The FDA product code is CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, a Class II (moderate risk) device regulated under 21 CFR 868.1400.