FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ASCENTIA HEARTSTATION ECG MANAGEMENT SYSTEM
K Number: K050858
·
Decision Jun 29, 2005
Classifications
1
FEI Numbers
177
Registration Numbers
177
Same Product Code
574
Applicant Total
6
Review Days
85
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Basic Information
- Device Name
- ASCENTIA HEARTSTATION ECG MANAGEMENT SYSTEM
- K Number
- K050858
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 870.2340
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Heartlab, Inc.
- Date Received
- April 5, 2005
- Decision Date
- June 29, 2005
- 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 |
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Other Clearances by Heartlab, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K050228 | AGFA HEARTLAB CARDIOVASCULAR | Feb 18, 2005 | Substantially Equivalent |
| K042042 | ULTRASOUND CAPTURE SYSTEM | Sep 21, 2004 | Substantially Equivalent |
| K040896 | MODIFICATION TO ENCOMPASS | Jul 16, 2004 | Substantially Equivalent |
| K954479 | DICOMVIEW | Feb 21, 1996 | Substantially Equivalent |
| K954860 | ECHONET | Dec 21, 1995 | Substantially Equivalent |