FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STANDARD WHEELCHAIR
K Number: K842719
·
Decision Jul 25, 1984
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
23
Applicant Total
8
Review Days
12
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Basic Information
- Device Name
- STANDARD WHEELCHAIR
- K Number
- K842719
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3880
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Greene International Corp.
- Date Received
- July 13, 1984
- Decision Date
- July 25, 1984
- Product Code
- IQC
- 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 |
|---|---|---|---|
| IQC | Wheelchair, Special Grade | FDA class 2 | Physical Medicine |
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Other Clearances by Greene International Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K883827 | MASKS, VARIOUS TYPES OF SURGICAL MASKS | Nov 17, 1988 | Substantially Equivalent |
| K883828 | CONE MASKS, VARIOUS TYPES OF SURGICAL CONE MASKS | Oct 3, 1988 | Substantially Equivalent |
| K880484 | SURGICAL GARMENTS | Jun 27, 1988 | Substantially Equivalent |
| K870617 | VARIOUS TYES OF SURGICAL GARMENTS | Mar 9, 1987 | Substantially Equivalent |
| K843075 | UTILITY SCISSORS DISPOSABLE ITEMS | Sep 5, 1984 | Substantially Equivalent |
| K843073 | FIXED VOL. DISPENSERS, ADJUST VOL-HUNPIP | Aug 24, 1984 | Substantially Equivalent |
| K843074 | DISPOS. & SPONGE FORCEPS PEAN ARTERY | Aug 17, 1984 | Substantially Equivalent |