FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PERITONEAL DIALYSIS SYSTEM
K Number: K760724
·
Decision Nov 23, 1976
Classifications
1
FEI Numbers
88
Registration Numbers
88
Same Product Code
88
Applicant Total
80
Review Days
57
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
- PERITONEAL DIALYSIS SYSTEM
- K Number
- K760724
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Physio-Control Corp.
- Date Received
- September 27, 1976
- Decision Date
- November 23, 1976
- Product Code
- EKX
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- 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 |
|---|---|---|---|
| EKX | Handpiece, Direct Drive, Ac-Powered | FDA class 1 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EKX), ordered by most recent decision date.
Alpha Endo Handpiece (Alpha Endo)
FDA 510(k)
FDA Class 1
·Dental
InnerView System
FDA 510(k)
FDA Class 1
·Dental
EnDrive (EnDriveUS)
FDA 510(k)
FDA Class 1
·Dental
Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO)
FDA 510(k)
FDA Class 1
·Dental
ChecQ (AC100)
FDA 510(k)
FDA Class 1
·Dental
HPR Cordless Hygiene Handpiece
FDA 510(k)
FDA Class 1
·Dental
Other Clearances by Physio-Control Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K991910 | LIFEPAK 12 BIPHASIC | Sep 3, 1999 | Substantially Equivalent - Subject to Tracking Reg. |
| K990338 | NIBP AND CO2 OPTIONS FOR THE PHYSIO-CONTROL LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEM | Sep 1, 1999 | Substantially Equivalent |
| K983393 | LIFEPAK 500 BIPHASIC | May 5, 1999 | Substantially Equivalent - Subject to Tracking Reg. |
| K973486 | LIFE PAK 12 | Jan 9, 1998 | Substantially Equivalent |
| K962359 | LIFEPAK 300 | Nov 6, 1997 | Substantially Equivalent |
| K955854 | LIFEPAK 500 | Nov 4, 1996 | Substantially Equivalent |
| K953204 | PEDIATRIC QUIK-COMBO | Jan 11, 1996 | Substantially Equivalent |
| K951593 | LIFEPAK 11 | Dec 29, 1995 | Substantially Equivalent |
| K945511 | LIFEPAK 10 DEFIBRILLATOR/MONITOR/PACEMAKER, AND LIFEPAK 11 CARDIAC MONITOR | Sep 26, 1995 | Substantially Equivalent |
| K943301 | QUIK COMBO | Feb 3, 1995 | Substantially Equivalent |