Submission Details
| 510(k) Number | K201666 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 19, 2020 |
| Decision Date | November 13, 2020 |
| Days to Decision | 147 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
Cleared
Traditional
SINGLE USE MANOMETER
Nov 2020
Decision
147d
Days
Class 2
Risk
About This 510(k) Submission
K201666 is an FDA 510(k) clearance for the SINGLE USE MANOMETER, a Monitor, Airway Pressure (includes Gauge And/or Alarm) (Class II — Special Controls, product code CAP), submitted by Flexicare Medical Limited. (Mountain Ash, GB). The FDA issued a Cleared decision on November 13, 2020, 147 days after receiving the submission on June 19, 2020. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2600.
Device Classification
| Product Code | CAP — Monitor, Airway Pressure (includes Gauge And/or Alarm) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 868.2600 |
Manufacturer
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