Panels › Anesthesiology › Product code BZR · Class 2
Mixer, Breathing Gases, Anesthesia Inhalation
Regulation 868.5330
0510(k)s in 12 months (55 all time)
0recalls in 12 months (3 all time)
3recalls that name a 510(k)
Top companies in BZR
| Company | 510(k)s | Recalls |
|---|---|---|
| Bird Products Corp. | 5 | 0 |
| Sk Med | 4 | 0 |
| Maxtec, Inc. | 3 | 0 |
| O-Two Medical Technologies, Inc. | 2 | 1 |
| Baldus Sedation GmbH & Co. KG | 2 | 0 |
| Hamilton Medical, Inc. | 2 | 0 |
| Parker Hannifin | 2 | 0 |
| Precision Medical, Inc. | 2 | 0 |
| Sechrist Industries, Inc. | 2 | 0 |
| Siemens Elema AB | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 15, 2018 | CAREstream Medical LLC CAREstream ProNox Nitrous Oxide Delivery System labeled as the following:
a. CMI-0100 PNX, Pro-Nox Mixer - Canadian;
b. CMI-0100-PNX-HS, Pro-Nox Complete Hospital Roll Stand System - Nitrous Oxi Terminated |
BZR | K113687 |
| May 14, 2018 | O-Two Medical Technologies, Inc. O-Two Equinox Relieve N2O/O2 Analgesic Gas Mixing and Delivery System
Model#: 01EQ1000 Terminated |
BZR | K113687 |
| Apr 14, 2005 | Maquet Inc KION Anesthesia System. Terminated |
BZR | K024213 |
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