FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ZEE EXTRICATION DEVICE
K Number: K812342
·
Decision Sep 21, 1981
Classifications
1
FEI Numbers
78
Registration Numbers
78
Same Product Code
6
Applicant Total
8
Review Days
34
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Basic Information
- Device Name
- ZEE EXTRICATION DEVICE
- K Number
- K812342
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3490
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Zee Medical Products Co., Inc.
- Date Received
- August 18, 1981
- Decision Date
- September 21, 1981
- Product Code
- IQF
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- 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 |
|---|---|---|---|
| IQF | Orthosis, Cervical-Thoracic, Rigid | FDA class 1 | Physical Medicine |
Similar 510(k) Clearances
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Other Clearances by Zee Medical Products Co., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K823501 | ZEE SPHYGMOMANOMETER | Jan 21, 1983 | Substantially Equivalent |
| K813156 | ULTRA-WIDE SAFETY SPECTACLE FRAME | Dec 14, 1981 | Substantially Equivalent |
| K813016 | ZEE TRACTION SPLINT | Nov 24, 1981 | Substantially Equivalent |
| K812814 | ZEE SURGICAL INSTRUMENTS | Nov 6, 1981 | Substantially Equivalent |
| K812564 | ZEE LIFE SUPPORT AIR PANTS | Oct 23, 1981 | Substantially Equivalent |
| K812284 | ZEE ELECTRODE-GEL | Sep 8, 1981 | Substantially Equivalent |
| K812022 | ZEE MANUAL RESUSCITATOR | Jul 31, 1981 | Substantially Equivalent |