FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HEMAWIPE SYSTEM, THE CIVILIZED TEST, MODIFICATION
K Number: K912979
·
Decision Oct 4, 1991
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
96
Applicant Total
26
Review Days
123
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Basic Information
- Device Name
- HEMAWIPE SYSTEM, THE CIVILIZED TEST, MODIFICATION
- K Number
- K912979
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.6550
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Labeltape Meditect, Inc.
- Date Received
- June 3, 1991
- Decision Date
- October 4, 1991
- Product Code
- KHE
- Advisory Committee
- Hematology
- 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 |
|---|---|---|---|
| KHE | Reagent, Occult Blood | FDA class 2 | Hematology |
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Other Clearances by Labeltape Meditect, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K951328 | LMI MEDICAL, ELECTRODE, ELECTROSURGICAL, DISPOSABLE DISPERSIVE ELECTRODE WITH CORD | Apr 25, 1995 | Substantially Equivalent |
| K915333 | ELECTRODE USING PROMEON RG-60 SERIES GEL | Jan 14, 1992 | Substantially Equivalent |
| K914871 | TRANS ELEC NERVE STIM/MUSCLE STIM ELEC W/POLY GEL | Dec 18, 1991 | Substantially Equivalent |
| K902738 | ELECTRO BLUE ECG ELECTRODE-PEDIATRIC CLOTH | Sep 4, 1990 | Substantially Equivalent |
| K902719 | SPECT.E.N.S. REPOSTION.-E FOAM PIN TYPE TENS ELECT | Jul 19, 1990 | Substantially Equivalent |
| K900656 | SPEC T.E.N.S. PREWIRED REPOSITIONABLE TENS ELECT. | Mar 1, 1990 | Substantially Equivalent |
| K896844 | BABE-EASE NEONATAL CLOTH ECG ELECTRODE | Feb 12, 1990 | Substantially Equivalent |
| K896936 | L.A.S.P. LUMBAR AND SACRAL PAD, REPOSITION. SNAP | Jan 22, 1990 | Substantially Equivalent |
| K894991 | ELECTRO BLUE ECG ELECT. FOAM, SILVER/SILVER CHLO. | Oct 26, 1989 | Substantially Equivalent |
| K894462 | CARE DISP. DIAG. ELECTRODES, SILVER/SILVER | Oct 12, 1989 | Substantially Equivalent |