FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MICROMED QRS CARD
K Number: K903722
·
Decision Dec 5, 1990
Classifications
1
FEI Numbers
177
Registration Numbers
177
Same Product Code
574
Applicant Total
5
Review Days
112
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
- MICROMED QRS CARD
- K Number
- K903722
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2340
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Nasiff Assoc., Inc.
- Date Received
- August 15, 1990
- Decision Date
- December 5, 1990
- Product Code
- DPS
- 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 |
|---|---|---|---|
| DPS | Electrocardiograph | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DPS), ordered by most recent decision date.
MAC 7 Resting ECG Analysis System
FDA 510(k)
FDA Class 2
·Cardiovascular
AccurECG Analysis System (v2.0)
FDA 510(k)
FDA Class 2
·Cardiovascular
Withings BeamO (SCT02)
FDA 510(k)
FDA Class 2
·Cardiovascular
Cardiologs Holter Platform
FDA 510(k)
FDA Class 2
·Cardiovascular
ZBPro Diagnostic
FDA 510(k)
FDA Class 2
·Cardiovascular
Masimo W1
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Nasiff Assoc., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K993616 | CARDIO-CARD INTERPRETATION SYSTEM I | Apr 10, 2000 | Substantially Equivalent |
| K972795 | CARDIO-CARD MANAGEMENT SYSTEM II | Feb 20, 1998 | Substantially Equivalent |
| K960544 | CARDIO-CARD HOLTER ECG MANAGEMENT SYSTEM | Aug 7, 1996 | Substantially Equivalent |
| K920020 | CARDIO-CARD ECG MANAGEMENT SYSTEM | Jul 9, 1992 | Substantially Equivalent |