FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
EASY-JET DEVICE
K Number: K972383
·
Decision Nov 23, 1999
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
5
Review Days
880
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Basic Information
- Device Name
- EASY-JET DEVICE
- K Number
- K972383
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.3850
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- A.Stein - Regulatory Affairs Consulting
- Date Received
- June 26, 1997
- Decision Date
- November 23, 1999
- Product Code
- KLZ
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- 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 |
|---|---|---|---|
| KLZ | Tube, Shunt, Endolymphatic With Valve | FDA class 2 | Ear, Nose, Throat |
Other Clearances by A.Stein - Regulatory Affairs Consulting
| K Number | Device Name | ||
|---|---|---|---|
| K973592 | WALKCARE P200 SYSTEM | May 20, 1999 | Substantially Equivalent |
| K982754 | EC-1000-7 DIGITAL ENDOSCOPY VIDEO CAMERA, MODELS EC 1000-7P (PAL) & EC 1000-7N (NTSC) | Jan 8, 1999 | Substantially Equivalent |
| K973590 | HEMORRELIEF DEVICE | Feb 5, 1998 | Substantially Equivalent |
| K973148 | MACOM | Nov 20, 1997 | Substantially Equivalent |