FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DASH IV
K Number: K912929
·
Decision Aug 13, 1991
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
86
Applicant Total
13
Review Days
39
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Basic Information
- Device Name
- DASH IV
- K Number
- K912929
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 870.2810
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Astro-Med, Inc.
- Date Received
- July 5, 1991
- Decision Date
- August 13, 1991
- 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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