FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ELECTRO BLUE ECG ELECTRODE-PEDIATRIC CLOTH
K Number: K902738
·
Decision Sep 4, 1990
Classifications
1
FEI Numbers
191
Registration Numbers
191
Same Product Code
328
Applicant Total
26
Review Days
75
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
- ELECTRO BLUE ECG ELECTRODE-PEDIATRIC CLOTH
- K Number
- K902738
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2360
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Labeltape Meditect, Inc.
- Date Received
- June 21, 1990
- Decision Date
- September 4, 1990
- Product Code
- DRX
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DRX | Electrode, Electrocardiograph | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DRX), ordered by most recent decision date.
Physiotrace
FDA 510(k)
FDA Class 2
·Cardiovascular
HMICRO WIRED C-PATCH ELECTRODE, TRADE NAME SUBJECT TO CHANGE
FDA 510(k)
FDA Class 2
·Cardiovascular
BIOMODULE 3-M1
FDA 510(k)
FDA Class 2
·Cardiovascular
CENTERRIDGE DIAGNOSTIC ECG ELECTRODE, CENTERRIDGE MONITORING ECG ELECTRODES
FDA 510(k)
FDA Class 2
·Cardiovascular
IP-SET
FDA 510(k)
FDA Class 2
·Cardiovascular
AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X
FDA 510(k)
FDA Class 2
·Cardiovascular
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 |
| K912979 | HEMAWIPE SYSTEM, THE CIVILIZED TEST, MODIFICATION | Oct 4, 1991 | 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 |