FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CARDIOVUE ACCESSORY CART
K Number: K820033
·
Decision Jan 22, 1982
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
86
Applicant Total
42
Review Days
16
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Basic Information
- Device Name
- CARDIOVUE ACCESSORY CART
- K Number
- K820033
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 870.2810
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Diasonics, Inc.
- Date Received
- January 6, 1982
- Decision Date
- January 22, 1982
- Product Code
- DSF
- 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 |
|---|---|---|---|
| DSF | Recorder, Paper Chart | FDA class 1 | Cardiovascular |
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Other Clearances by Diasonics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K962662 | VINGMED SOUND COLOR FLOW MAPPING SYSTEM | Jan 2, 1997 | Substantially Equivalent |
| K924079 | CFM-800 COLOR FLOW MAPPING SYSTEM | Sep 28, 1993 | Substantially Equivalent |
| K911435 | CPA/3.5 MHZ PROBE | Sep 11, 1992 | Substantially Equivalent |
| K905200 | SACA, 3.5 MHZ PROBE | Apr 2, 1992 | Substantially Equivalent |
| K903562 | CW DOPPLER 2.25 MHZ PROBE | Mar 2, 1992 | Substantially Equivalent |
| K903984 | CW DOPPLER/4.5 MHZ | Jun 14, 1991 | Substantially Equivalent |
| K896637 | ACCESS(TM), SOFTWARE RELEASE 4.11P | Jan 22, 1990 | Substantially Equivalent |
| K893518 | MT/S SOFTWARE RELEASE 5.0. | Oct 27, 1989 | Substantially Equivalent |
| K894290 | ACCESS TM | Sep 7, 1989 | Substantially Equivalent |
| K893881 | ACCESS TM | Jun 23, 1989 | Substantially Equivalent |