510(k) K843223 ยท BTM Ventilator, Emergency, Manual (Resuscitator)
FLOW CONTROLLER
| Applicant | Precision Medical, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Sep 27, 1984 |
| Received | Aug 16, 1984 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K843223
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 9, 2010 | Precision Medical, Inc. PM1000 Flow Selector - An accessory to an emergency ventilator (resuscitator). The selector is attached to a flowmeter and is used to direct the outlet flow from any standard flowmeter to any one of Terminated |
BTM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.