Submission Details
| 510(k) Number | K192595 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 20, 2019 |
| Decision Date | December 17, 2019 |
| Days to Decision | 88 days |
| Submission Type | Special |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
Cleared
Special
ExSpiron 2Xi
Dec 2019
Decision
88d
Days
Class 2
Risk
About This 510(k) Submission
K192595 is an FDA 510(k) clearance for the ExSpiron 2Xi, a Spirometer, Monitoring (w/wo Alarm) (Class II — Special Controls, product code BZK), submitted by Respiratory Motion (Watertown, US). The FDA issued a Cleared decision on December 17, 2019, 88 days after receiving the submission on September 20, 2019. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1850.
Device Classification
| Product Code | BZK — Spirometer, Monitoring (w/wo Alarm) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 868.1850 |
Manufacturer
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