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6036
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2129
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2002
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1370
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1298
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1167
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1154
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1142
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1020
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1016
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510k Database
Manufacturers
US
Invacare Corp.
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Medical Device Manufacturer
·
US , Elyria , OH
Invacare Corp. - FDA 510(k) Cleared Devices
111 submissions
·
110 cleared
·
Since 1980
Official Website
111
Total
110
Cleared
0
Denied
29
devices
26-29 of 29
Filters
1
2
Cleared
Jul 29, 1985
PRIME AIRE O2 PLUS 2
K851437
·
CAW
Anesthesiology
·
110d
Cleared
Jul 29, 1985
MOBILAIRE II(P2A) OXYGEN CONCENTRATOR
K851438
·
CAW
Anesthesiology
·
110d
Cleared
Jul 29, 1985
MOBILAIRE, PLA-01 OXYGEN CONCENTRATOR
K851439
·
CAW
Anesthesiology
·
110d
Cleared
Jul 08, 1985
NEBULAIRE (IRC 1040) NEBULIZER PUMP
K851436
·
CAF
Anesthesiology
·
89d
1
2
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111
Physical Medicine
76
Anesthesiology
29
General Hospital
4
Cardiovascular
1
Toxicology
1