FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ASPR-CARE CLOSED SYSTEM,DUAL SWIVEL PIECE T,SHEATHED SUCTION CATHETER,BRONCHOSOPE ADAPTER,IN-LINE SPECIMEN TRAP
K Number: K972139
·
Decision Sep 3, 1997
Classifications
1
FEI Numbers
75
Registration Numbers
75
Same Product Code
208
Applicant Total
45
Review Days
89
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Basic Information
- Device Name
- ASPR-CARE CLOSED SYSTEM,DUAL SWIVEL PIECE T,SHEATHED SUCTION CATHETER,BRONCHOSOPE ADAPTER,IN-LINE SPECIMEN TRAP
- K Number
- K972139
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5915
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Davis & Geck, Inc.
- Date Received
- June 6, 1997
- Decision Date
- September 3, 1997
- Product Code
- BTM
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| BTM | Ventilator, Emergency, Manual (Resuscitator) | FDA class 2 | Anesthesiology |
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FDA 510(k)
FDA Class 2
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Other Clearances by Davis & Geck, Inc.
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|---|---|---|---|
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| K970857 | ARGYLE AQUA-SEAL ALL PURPOSE AUTOTRANSFUSION CHEST DRAINAGE UNIT AND OPTIONAL ARGYLE AQUA-SEAL EVACUATING AUTOTRANSFUSIO | Nov 5, 1997 | Substantially Equivalent |
| K972566 | DEXON VIOLET | Aug 14, 1997 | Substantially Equivalent |
| K962971 | POLYPROPYLENE MESH (VARIOUS SIZES) | Sep 16, 1996 | Substantially Equivalent |
| K955722 | FLEXON TEMPORARY CARDIAC PACER LEAD | Mar 15, 1996 | Substantially Equivalent |