510k
Database
Specialties
Anesthesiology
527
Cardiovascular
1633
Chemistry
356
Dental
1304
Ear, Nose, Throat
239
Gastroenterology & Urology
946
General & Plastic Surgery
2157
General Hospital
2020
Hematology
126
Immunology
92
Medical Genetics
8
Microbiology
459
Neurology
948
Obstetrics & Gynecology
430
Ophthalmic
272
Orthopedic
2780
Pathology
52
Physical Medicine
515
Radiology
2364
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
376
FXX
Mask, Surgical
357
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
297
QIH
Automated Radiological Image...
275
IYN
System, Imaging, Pulsed Doppler,...
272
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
220
NHA
Abutment, Implant, Dental,...
205
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Enact Health Management Systems
Medical Device Manufacturer
·
US , North Attleboro , MA
Enact Health Management Systems - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 1994
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Enact Health Management Systems
Anesthesiology
✕
3
devices
1-3 of 3
Filters
Cleared
Oct 29, 1998
AIRWATCH II ZONELESS
K982675
·
BZH
Anesthesiology
·
90d
Cleared
Oct 29, 1998
AIRWATCH II ZONE
K982676
·
BZH
Anesthesiology
·
90d
Cleared
Nov 16, 1994
AIRWATCH MONITOR
K941226
·
BZH
Anesthesiology
·
247d
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3
Anesthesiology
3