FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LP-3000 HIGH RESOLUTION ELECTROCARDIOGRAPH
K Number: K872928
·
Decision Jan 6, 1988
Classifications
1
FEI Numbers
178
Registration Numbers
178
Same Product Code
429
Applicant Total
8
Review Days
163
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Basic Information
- Device Name
- LP-3000 HIGH RESOLUTION ELECTROCARDIOGRAPH
- K Number
- K872928
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1425
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Fidelity Medical, Inc.
- Date Received
- July 27, 1987
- Decision Date
- January 6, 1988
- 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 |
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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 |
| K903774 | LP-PLUS | Aug 29, 1991 | Substantially Equivalent |
| K864614 | LP-3 ELECTROCARDIOGRAPH | Jun 16, 1987 | Substantially Equivalent |
| K841780 | CLINICAL ELECTRONIC THERMOMETER | Jul 6, 1984 | Substantially Equivalent |