Company ยท US
Accutron, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1997 to 2005. Name variants (Inc, Corp, punctuation) are merged.
5510(k) clearances (0 in 12 months)
4recalls (0 in 12 months)
4recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 23, 2005 | K052335 | ANALGESIA GAS MACHINE, MODEL DIGITAL ULTRA Accutron, Inc. | BSZ |
| Mar 12, 2004 | K033503 | RFS VACUUM GAUGE SCAVENGING CIRCUIT Accutron, Inc. | CBN |
| Oct 27, 1999 | K992421 | GUARDIAN LOW PRESSURE ALARM ACCESSORY, MODEL 34076 Accutron, Inc. | BSZ |
| Mar 28, 1997 | K970046 | UNIVERSAL LOW PROFILE NASAL HOODS(1250,1275,1350,1450,1475,1550) Accutron, Inc. | KHA |
| Mar 28, 1997 | K965239 | PIP LOW PROFILE SCAVENGING SYSTEM(260 AND 261)/UNIVERSAL LOW PROFILE SCAVENGING SYSTEM(260-U AND 261-U) Accutron, Inc. | CBN |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | K052335 |
| Oct 9, 2012 | Accutron Inc CM Flowmeter Pkg H, Model #36700, Serial #
13749
Product Usage:
Conscious Sedation Unit Analgesia Gas Machine. Terminated |
BSZ | K052335 |
| 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 | K052335 |
| 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 | K052335 |