FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ECHONET
K Number: K954860
·
Decision Dec 21, 1995
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
6
Review Days
59
Basic Information
- Device Name
- ECHONET
- K Number
- K954860
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- HEARTLAB, INC.
- Date Received
- October 23, 1995
- Decision Date
- December 21, 1995
- Product Code
- LLZ
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | FDA class 2 | Radiology |
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Other Clearances by HEARTLAB, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K050858 | ASCENTIA HEARTSTATION ECG MANAGEMENT SYSTEM | Jun 29, 2005 | Substantially Equivalent |
| 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 |