510k
Database
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Anesthesiology
525
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1613
Chemistry
356
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1304
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237
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934
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2142
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2013
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126
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91
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8
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458
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942
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429
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272
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2757
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52
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515
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2354
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155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
374
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Mask, Surgical
357
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Powered Laser Surgical Instrument
351
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Electrosurgical, Cutting &...
295
QIH
Automated Radiological Image...
275
IYN
System, Imaging, Pulsed Doppler,...
271
HRS
Plate, Fixation, Bone
268
OLO
Orthopedic Stereotaxic Instrument
218
NHA
Abutment, Implant, Dental,...
205
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Spirometrics Medical Equipment Co.
Medical Device Manufacturer
·
US , N. Attleboro , MA
Spirometrics Medical Equipment Co. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 1996
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Spirometrics Medical Equipment Co.
Anesthesiology
✕
3
devices
1-3 of 3
Filters
Cleared
Jan 18, 2001
PC FLOW +
K001528
·
BZG
Anesthesiology
·
246d
Cleared
Nov 24, 1998
FLOWMATE II PLUS, MODEL #4000
K982956
·
BZG
Anesthesiology
·
92d
Cleared
Apr 12, 1996
FLOWMATE LTE
K954759
·
BZG
Anesthesiology
·
178d
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3
Anesthesiology
3