FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RHYTHMSCAN PRECISION 6000
K Number: K914577
·
Decision May 8, 1992
Classifications
1
FEI Numbers
178
Registration Numbers
178
Same Product Code
429
Applicant Total
1
Review Days
206
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
- RHYTHMSCAN PRECISION 6000
- K Number
- K914577
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1425
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Precision Health Care Systems, Inc.
- Date Received
- October 15, 1991
- Decision Date
- May 8, 1992
- Product Code
- DQK
- 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 |
|---|---|---|---|
| DQK | Computer, Diagnostic, Programmable | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DQK), ordered by most recent decision date.
OneStim-DUO Cardiac Stimulator (MP5003-4CO)
FDA 510(k)
FDA Class 2
·Cardiovascular
Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Catheter, 75cm (C00751);IOPS Viewpoint Simple Curve Catheter, 125cm (C01251);IOPS Viewpoint Double Curve Catheter, 75cm (C00752);IOPS Viewpoint Double Curve Catheter, 125cm (C02152);IOPS Guidewire 2 (ATW-2);IOPS Fiducial Tracking Pad (T02111);IOPS Guidewire Handle (H01035)
FDA 510(k)
FDA Class 2
·Cardiovascular
ZEUS Platform (FG0501US)
FDA 510(k)
FDA Class 2
·Cardiovascular
EnSite X EP System
FDA 510(k)
FDA Class 2
·Cardiovascular
ACORYS MAPPING SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
Synchrony
FDA 510(k)
FDA Class 2
·Cardiovascular