FDA 510(k)
Substantially Equivalent
🇺🇸 United States
EMERGENCY ROOM PACK
K Number: K850338
·
Decision Mar 25, 1985
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
7
Review Days
56
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- EMERGENCY ROOM PACK
- K Number
- K850338
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Marwood Medical, Inc.
- Date Received
- January 28, 1985
- Decision Date
- March 25, 1985
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- Third Party
- N
Other Clearances by Marwood Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K850340 | EYE PROCEDURE PACK | May 22, 1985 | Substantially Equivalent |
| K850339 | SPECIAL PROCEDURES PACK | Mar 12, 1985 | Substantially Equivalent |
| K850337 | CARDIAC CATHETERIZATION PACK | Feb 25, 1985 | Substantially Equivalent |
| K850341 | CARDIOVASCULAR SET UP | Feb 25, 1985 | Substantially Equivalent |
| K840620 | TPN/CVP DRESSING CHANGE KIT | May 30, 1984 | Substantially Equivalent |
| K840619 | I.V. START KIT | Mar 27, 1984 | Substantially Equivalent |