FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THE ACTA FORMULA
K Number: K922703
·
Decision Apr 27, 1993
Classifications
1
FEI Numbers
184
Registration Numbers
184
Same Product Code
570
Applicant Total
39
Review Days
326
Basic Information
- Device Name
- THE ACTA FORMULA
- K Number
- K922703
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2340
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- BIOSOUND, INC.
- Date Received
- June 5, 1992
- Decision Date
- April 27, 1993
- 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 BIOSOUND, INC.
| K Number | Device Name | ||
|---|---|---|---|
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| K963262 | ARTOSCAN M | Mar 28, 1997 | Substantially Equivalent |
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| K953716 | INTRACAVITY TRANSDUCERS | Apr 17, 1996 | Substantially Equivalent |
| K953530 | DIAGNOSTIC ULTRASOUND TRANDUCERS P10A, P12A, PT10A, PA11-A | Apr 8, 1996 | Substantially Equivalent |
| K953819 | DIAGNOSTIC ULTRASOUND TRANDUCER | Mar 1, 1996 | Substantially Equivalent |
| K953759 | DIAGNOSTIC ULTRASOUND TRANSDUCER | Mar 1, 1996 | Substantially Equivalent |
| K955458 | ULTRASOUND PROBE BIOPSY ACCESSORIES | Feb 12, 1996 | Substantially Equivalent |
| K953579 | TEE PROBE | Feb 2, 1996 | Substantially Equivalent |