FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INFANT ELECTRODE BELT
K Number: K830362
·
Decision Jun 3, 1983
Classifications
1
FEI Numbers
191
Registration Numbers
191
Same Product Code
328
Applicant Total
13
Review Days
120
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Basic Information
- Device Name
- INFANT ELECTRODE BELT
- K Number
- K830362
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2360
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Sentry Medical Products, Inc.
- Date Received
- February 3, 1983
- Decision Date
- June 3, 1983
- 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 |
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Other Clearances by Sentry Medical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K962122 | SENTRY RADIOTRANSLUCENT ECG ELECTRODES | Jul 24, 1996 | Substantially Equivalent |
| K955636 | SENTRY DISPOSABLE DISPERSIVE ELECTRODE | Mar 27, 1996 | Substantially Equivalent |
| K942827 | SENTRY INSERTION TRAY | Nov 2, 1994 | Substantially Equivalent |
| K934000 | SENTRY AQUEOUS GEL ECG ELECTRODES | Aug 30, 1994 | Substantially Equivalent |
| K935098 | BABY BOARD | Feb 15, 1994 | Substantially Equivalent |
| K933603 | LEADWIRE | Jan 18, 1994 | Substantially Equivalent |
| K932704 | PATIENT CABLE | Dec 27, 1993 | Substantially Equivalent |
| K881670 | ACCUTEMP PLUS | Nov 22, 1988 | Substantially Equivalent |
| K881343 | DURADERM BUTTERFLY | May 4, 1988 | Substantially Equivalent |
| K851522 | DIAGNOSTIC ECG DISPOSABLE ELECTRODE | Oct 24, 1985 | Substantially Equivalent |