FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LP-PLUS
K Number: K903774
·
Decision Aug 29, 1991
Classifications
1
FEI Numbers
177
Registration Numbers
177
Same Product Code
574
Applicant Total
8
Review Days
374
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
- LP-PLUS
- K Number
- K903774
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2340
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Fidelity Medical, Inc.
- Date Received
- August 20, 1990
- Decision Date
- August 29, 1991
- 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 Fidelity Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K983088 | INSTACINE D-2000 | Sep 22, 1998 | Substantially Equivalent |
| K942558 | INSTACINE | May 30, 1995 | Substantially Equivalent |
| K942504 | INSTASPOT | May 5, 1995 | Substantially Equivalent |
| K941917 | FLUOROPLUA CARDIAC AND/OR INSTAVIEW | Feb 24, 1995 | Substantially Equivalent |
| K872928 | LP-3000 HIGH RESOLUTION ELECTROCARDIOGRAPH | Jan 6, 1988 | Substantially Equivalent |
| K864614 | LP-3 ELECTROCARDIOGRAPH | Jun 16, 1987 | Substantially Equivalent |
| K841780 | CLINICAL ELECTRONIC THERMOMETER | Jul 6, 1984 | Substantially Equivalent |