FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACTA GENOS ELECTROCARDIOGRAPH
K Number: K884800
·
Decision Jun 22, 1989
Classifications
1
FEI Numbers
177
Registration Numbers
177
Same Product Code
574
Applicant Total
14
Review Days
218
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Basic Information
- Device Name
- ACTA GENOS ELECTROCARDIOGRAPH
- K Number
- K884800
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2340
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Parexel Intl. Corp.
- Date Received
- November 16, 1988
- Decision Date
- June 22, 1989
- 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 Parexel Intl. Corp.
| K Number | Device Name | ||
|---|---|---|---|
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| K862415 | TYPE 633 COMPUTED RADIOGRAPHY (CR) FILM | Jul 1, 1986 | Substantially Equivalent |
| K862416 | FTI 100 MEDICAL THERMAL IMAGER | Jul 1, 1986 | Substantially Equivalent |
| K853295 | EMODREN EXCHANGEABLE PLASTIC BELLOWS | Aug 20, 1985 | Substantially Equivalent |
| K853296 | EMODREN GUIDE NEEDLE FOR DRAINAGE TUBE & EMODREN | Aug 15, 1985 | Substantially Equivalent |
| K851322 | PERSONAL C3 3-CHANNEL ELECTROCARDIOGRAPH | May 16, 1985 | Substantially Equivalent |