FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
SONIC SHOT GX
K Number: K091734
·
Decision May 21, 2010
Classifications
1
FEI Numbers
41
Registration Numbers
41
Same Product Code
21
Applicant Total
8
Review Days
344
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Basic Information
- Device Name
- SONIC SHOT GX
- K Number
- K091734
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1650
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nemoto Kyorindo Co., Ltd.
- Date Received
- June 11, 2009
- Decision Date
- May 21, 2010
- Product Code
- IZQ
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- RA
- 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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Other Clearances by Nemoto Kyorindo Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K242212 | Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit) | Aug 27, 2024 | Substantially Equivalent |
| K173450 | PRESS DUO elite, PRESS DUO elite AG | Feb 7, 2018 | Substantially Equivalent |
| K133189 | DUAL SHOT ALPHA 7 | Jun 30, 2014 | Substantially Equivalent |
| K092896 | REMPRESS AND ANGIOGRAPHY CONTRAST DELIVERY SYSTEM REMPRESS | Oct 29, 2010 | Substantially Equivalent |
| K071691 | DUAL SHOT ALPHA | Dec 19, 2007 | Substantially Equivalent |
| K062168 | CONTRAST DELIVERY SYSTEM - DUAL SHOT ALPHA | Aug 18, 2006 | Substantially Equivalent |
| K052633 | DUAL SHOT - CONTRAST DELIVERY SYSTEM | Oct 17, 2005 | Substantially Equivalent |