FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MONITOR/VITAL SIGNS TRAY
K Number: K811915
·
Decision Jul 28, 1981
Classifications
1
FEI Numbers
234
Registration Numbers
234
Same Product Code
4
Applicant Total
56
Review Days
27
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Basic Information
- Device Name
- MONITOR/VITAL SIGNS TRAY
- K Number
- K811915
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6265
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- American Hospital Supply Corp.
- Date Received
- July 1, 1981
- Decision Date
- July 28, 1981
- Product Code
- FME
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FME | Gown, Examination | FDA class 1 | General Hospital |
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Other Clearances by American Hospital Supply Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K854739 | AMERICAN STERILE SURGICAL ABSORBENT TOWEL | Dec 27, 1985 | Substantially Equivalent |
| K854759 | AMERICAN STERILE MAYO STAND TRAY | Dec 17, 1985 | Substantially Equivalent |
| K832826 | AAP DOSIMETRY RELEASE OR BASIN SETS | Apr 23, 1984 | Substantially Equivalent |
| K830546 | DOSIMETRIC RELEASE | May 25, 1983 | Substantially Equivalent |
| K822990 | CONVERTORS PRIMARY WOUND DRESSING II | Apr 12, 1983 | Substantially Equivalent |
| K830343 | CONTAINER W/PRIMING SOLUTION | Mar 17, 1983 | Substantially Equivalent |
| K830301 | STRATUS FLUOROMETRIC ENZYME IMMUN0- | Feb 25, 1983 | Substantially Equivalent |
| K822755 | LATEX PENROSE TUBING | Jan 21, 1983 | Substantially Equivalent |
| K823418 | HEYER-SCHUTE UNIVERSAL URETERAL STENT | Dec 3, 1982 | Substantially Equivalent |
| K822966 | CONVERTORS DISPOSABLE DRESSING SPONGE | Nov 5, 1982 | Substantially Equivalent |