FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MYELOGRAPHY TRAY W/CHYNN MYELOGRAPHY N
K Number: K760641
·
Decision Oct 8, 1976
Classifications
1
FEI Numbers
41
Registration Numbers
41
Same Product Code
21
Applicant Total
632
Review Days
24
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Basic Information
- Device Name
- MYELOGRAPHY TRAY W/CHYNN MYELOGRAPHY N
- K Number
- K760641
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1650
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
- Date Received
- September 14, 1976
- Decision Date
- October 8, 1976
- Product Code
- IZQ
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| IZQ | Injector, Contrast Medium, Automatic | FDA class 2 | Cardiovascular |
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ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)
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ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)
FDA 510(k)
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| K993186 | SYNERCID, 15 UG, BBL SENSI-DISC | Nov 3, 1999 | Substantially Equivalent |
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