FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KWIK-AWA VEST
K Number: K791363
·
Decision Aug 3, 1979
Classifications
1
FEI Numbers
125
Registration Numbers
125
Same Product Code
190
Applicant Total
40
Review Days
17
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
- KWIK-AWA VEST
- K Number
- K791363
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2910
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Medical Specialties, Inc.
- Date Received
- July 17, 1979
- Decision Date
- August 3, 1979
- Product Code
- DRG
- 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 |
|---|---|---|---|
| DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DRG), ordered by most recent decision date.
Perin Health System (PHD80060-2)
FDA 510(k)
FDA Class 2
·Cardiovascular
EasyTeleMed (2.0.2)
FDA 510(k)
FDA Class 2
·Cardiovascular
TeleRehab Aermos Cardiopulmonary Rehabilitation
FDA 510(k)
FDA Class 2
·Cardiovascular
iBSM
FDA 510(k)
FDA Class 2
·Cardiovascular
UbiqVue 2A Multi-parameter System (UX2550)
FDA 510(k)
FDA Class 2
·Cardiovascular
BioButton System
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Medical Specialties, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K946201 | STAND, INFUSION | Apr 18, 1995 | Substantially Equivalent |
| K931947 | CHECKPOINT | Jun 18, 1993 | Substantially Equivalent |
| K926095 | REFRACTROL-SP | Jan 26, 1993 | Substantially Equivalent |
| K924926 | MSI-HCT | Jan 7, 1993 | Substantially Equivalent |
| K896566 | MODIFIED FOX EXTRA GRAM NEGATIVE AND POSITIVE | Feb 9, 1990 | Substantially Equivalent |
| K883703 | MSI-CAL 7 | Nov 22, 1988 | Substantially Equivalent |
| K883851 | MSI-CAL 8 | Nov 22, 1988 | Substantially Equivalent |
| K883850 | MSI-CAL 16 | Nov 22, 1988 | Substantially Equivalent |
| K880608 | MSI-PC | Mar 21, 1988 | Substantially Equivalent |
| K880270 | MSI-DIFF PLUS | Mar 1, 1988 | Substantially Equivalent |