FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BLOOD GLUCOSE MONITOR
K Number: K834099
·
Decision Feb 3, 1984
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
257
Applicant Total
35
Review Days
67
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Basic Information
- Device Name
- BLOOD GLUCOSE MONITOR
- K Number
- K834099
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2300
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Healthdyne, Inc.
- Date Received
- November 28, 1983
- Decision Date
- February 3, 1984
- Product Code
- JJQ
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | FDA class 1 | Clinical Chemistry |
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| K924146 | OH-500 OXYGEN CONCENTRATOR | Jan 7, 1993 | Substantially Equivalent |
| K922623 | NEBULIZER SYSTEM | Dec 1, 1992 | Substantially Equivalent |
| K910118 | DATA RECORDER | Feb 14, 1991 | Substantially Equivalent |
| K903287 | MODEL 900S APNEA/HEART MONITOR | Aug 17, 1990 | Substantially Equivalent |
| K894030 | MODEL 37 UTERINE CONTRACTION ACTIVITY MONITOR | Jan 22, 1990 | Substantially Equivalent |
| K892006 | HEALTHDYNE'S APNEA/HEART MONITOR, MODEL 900S | May 23, 1989 | Substantially Equivalent |