Submission Details
| 510(k) Number | K120463 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 15, 2012 |
| Decision Date | July 27, 2012 |
| Days to Decision | 163 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
Cleared
Traditional
MOJO, VERASEAL
Jul 2012
Decision
163d
Days
Class 2
Risk
About This 510(k) Submission
K120463 is an FDA 510(k) clearance for the MOJO, VERASEAL, a Ventilator, Non-continuous (respirator) (Class II — Special Controls, product code BZD), submitted by Sleepnet Corporation (Bonita Springs, US). The FDA issued a Cleared decision on July 27, 2012, 163 days after receiving the submission on February 15, 2012. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.
Device Classification
| Product Code | BZD — Ventilator, Non-continuous (respirator) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 868.5905 |
Manufacturer
Similar Devices — BZD Ventilator, Non-continuous (respirator)
All 454
K251847 · Sleepnet Corporation
· Jan 2026
K253939 · RemSleep Holdings, Inc.
· Jan 2026
K251770 · Sleepres, Inc.
· Dec 2025
K251657 · ResMed Corp
· Dec 2025
K243583 · Fisher & Paykel Healthcare Limited
· Jun 2025
K250624 · ResMed Corp
· May 2025
More from Sleepnet Corporation
View all
K251847
· BZD · Jan 2026
K241830
· BZD · Oct 2024
K241943
· CBK · Aug 2024
K241661
· BZD · Jul 2024
K241520
· CBK · Jun 2024