510(k) K052335 ยท BSZ Gas-Machine, Anesthesia
ANALGESIA GAS MACHINE, MODEL DIGITAL ULTRA
| Applicant | Accutron, Inc., Golden CO, US |
| Decision | Substantially Equivalent, Nov 23, 2005 |
| Received | Aug 26, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052335
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 9, 2012 | Accutron Inc Flow Meter, CM Assembly, Model #27025, Serial # 13686, 13690, 13712, 13793.
Flowmeter, CM Assembly, Model#31970, Serial#13692.
Product Usage:
Conscious Sedation Unit Analgesia Gas Machine. Terminated |
BSZ | None listed |
| Oct 9, 2012 | Accutron Inc Ultra PC% Cabinet Mount Package G, Model #36600,
Serial # 13593, 13594, 13595, 13596, 13597, 13598, 13599, 13600, 13602, 13605, 13610, 13611, 13612, 13615, 13616, 13617, 13621, 13622, 13624, 13625, 1 Terminated |
BSZ | None listed |
| Oct 9, 2012 | Accutron Inc CM Flowmeter Pkg H, Model #36700, Serial #
13749
Product Usage:
Conscious Sedation Unit Analgesia Gas Machine. Terminated |
BSZ | None listed |
| Oct 9, 2012 | Accutron Inc Newport Portable Package, Model #50000, Serial #
13591, 13592, 13604, 13606, 13614, 13662, 13663, 13664, 13726, 13731, 13733, 13736, 13737, 13738, 13740, 13768, 13770, 13771, 13772, 13784, 13787.
Terminated |
BSZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.