510k
Database
Specialties
Anesthesiology
540
Cardiovascular
1660
Chemistry
362
Dental
1323
Ear, Nose, Throat
244
Gastroenterology & Urology
957
General & Plastic Surgery
2177
General Hospital
2039
Hematology
126
Immunology
97
Medical Genetics
8
Microbiology
462
Neurology
960
Obstetrics & Gynecology
433
Ophthalmic
274
Orthopedic
2846
Pathology
52
Physical Medicine
515
Radiology
2417
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
382
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
301
IYN
System, Imaging, Pulsed Doppler,...
288
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
214
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S & M Instrument Co.
Medical Device Manufacturer
·
US , Doylestown , PA
S & M Instrument Co. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 1988
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - S & M Instrument Co.
Anesthesiology
✕
4
devices
1-4 of 4
Filters
Cleared
Apr 14, 1995
PORTA-SCREEN SPIROMETER
K951367
·
BZG
Anesthesiology
·
18d
Cleared
Nov 28, 1994
PORTA-RESP MONITOR
K943146
·
CAP
Anesthesiology
·
151d
Cleared
Dec 23, 1992
THE KEYSTONE SYSTEM
K920877
·
BZG
Anesthesiology
·
301d
Cleared
Dec 16, 1988
DSM-1 DOSIMETER
K884051
·
CAF
Anesthesiology
·
81d
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4
Anesthesiology
4