FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MINI LANCET-BLOOD LANCET
K Number: K830705
·
Decision Apr 8, 1983
Classifications
1
FEI Numbers
219
Registration Numbers
219
Same Product Code
4
Applicant Total
14
Review Days
32
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Basic Information
- Device Name
- MINI LANCET-BLOOD LANCET
- K Number
- K830705
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6230
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Pharmaquest Corp.
- Date Received
- March 7, 1983
- Decision Date
- April 8, 1983
- Product Code
- FMA
- 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 |
|---|---|---|---|
| FMA | Depressor, Tongue, Non-Surgical | FDA class 1 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FMA), ordered by most recent decision date.
AROMATIC AND FLAVORED TONGUE DEPRESSOR
FDA 510(k)
FDA Class 1
·General Hospital
TONGUE DEPRESSOR
FDA 510(k)
FDA Class 1
·General Hospital
BITE STICK
FDA 510(k)
FDA Class 1
·General Hospital
MOUTH WASH TRAY
FDA 510(k)
FDA Class 1
·General Hospital
Other Clearances by Pharmaquest Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K945519 | FACE (FLUOROPHORE-ASSISTED-CARBOHYDRATE-ELECTROPHORESIS) URINARY CARBOHYDRATE ANALYSIS SYSTEM | Nov 3, 1995 | Substantially Equivalent |
| K833236 | TELEPHONE TRANSMITTER T-10 EEG | Nov 29, 1983 | Substantially Equivalent |
| K833880 | TELEPHONIC RECEIVER R-10 EEG | Nov 29, 1983 | Substantially Equivalent |
| K822976 | HYPOCOUNT A | Nov 16, 1982 | Substantially Equivalent |
| K822486 | HOME BLOOD GLUCOSE MONITOR | Nov 5, 1982 | Substantially Equivalent |
| K820248 | RODDER VOLUME VENTILATOR | Apr 16, 1982 | Substantially Equivalent |
| K812849 | PTT-200 TELEPHONIC PULMONARY TRANSMITT | Dec 3, 1981 | Substantially Equivalent |
| K812850 | PTT-200 PULMONARY RECEIVER/MICROPROCES | Dec 3, 1981 | Substantially Equivalent |
| K813010 | EEG TELEPHONE TRANSMITTER, MODEL #T-7 | Nov 16, 1981 | Substantially Equivalent |
| K812683 | NEONATE FLEXFLOAT | Oct 13, 1981 | Substantially Equivalent |