FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CARDIAC WALL MOTION DEVICE
K Number: K833728
·
Decision Feb 10, 1984
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
113
Applicant Total
17
Review Days
108
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
- CARDIAC WALL MOTION DEVICE
- K Number
- K833728
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2770
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Intl. Medical, Inc.
- Date Received
- October 25, 1983
- Decision Date
- February 10, 1984
- Product Code
- DSB
- 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 |
|---|---|---|---|
| DSB | Plethysmograph, Impedance | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DSB), ordered by most recent decision date.
BCM2-Body Composition Monitor
FDA 510(k)
FDA Class 2
·Cardiovascular
Re:Balans
FDA 510(k)
FDA Class 2
·Cardiovascular
Edema Guard Monitor (EGM) CardioSet-001
FDA 510(k)
FDA Class 2
·Cardiovascular
SOZO Pro
FDA 510(k)
FDA Class 2
·Cardiovascular
Zynex Monitoring System, Model CM-1600
FDA 510(k)
FDA Class 2
·Cardiovascular
Bodyport Cardiac Scale
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Intl. Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K970507 | PEAK FLOW METER | Jun 13, 1997 | Substantially Equivalent |
| K943078 | HOT BIOPSY FORCEPS | Nov 14, 1994 | Substantially Equivalent |
| K940370 | AMERICAN CATHETER E.R.C.P. CANNULA | Aug 17, 1994 | Substantially Equivalent |
| K940335 | AMERICAN CATHETER POLY-SNARE | Jul 21, 1994 | Substantially Equivalent |
| K942068 | AMERICAN CATHETER SPHINCTEROTOME | Jun 24, 1994 | Substantially Equivalent |
| K930406 | DURHAM; MIN BORE LUER LOCK EXTENSION SET | Sep 3, 1993 | Substantially Equivalent |
| K930410 | DURHAM; LUER LOCK EXTENSION SET | Sep 3, 1993 | Substantially Equivalent |
| K923200 | AMCATH DISPOSABLE CYTOLOGY BRUSH | Dec 7, 1992 | Substantially Equivalent |
| K915142 | AMCATH DISPOSABLE BIOPSY FORCEPS | Jan 10, 1992 | Substantially Equivalent |
| K912927 | AMCATH DISPOSABLE TROCAR AND TROCAR SLEEVE | Sep 19, 1991 | Substantially Equivalent |