FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TREND II ANEROID
K Number: K780598
·
Decision Jun 6, 1978
Classifications
1
FEI Numbers
428
Registration Numbers
428
Same Product Code
1216
Applicant Total
127
Review Days
57
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Basic Information
- Device Name
- TREND II ANEROID
- K Number
- K780598
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1130
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Abco Dealers, Inc.
- Date Received
- April 10, 1978
- Decision Date
- June 6, 1978
- Product Code
- DXN
- 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 |
|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | FDA class 2 | Cardiovascular |
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|---|---|---|---|
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| K880892 | BLOOD COLLECTING NEEDLE AND HOLDERS | Apr 21, 1988 | Substantially Equivalent |
| K880894 | ALLERGIST SYRINGES | Mar 31, 1988 | Substantially Equivalent |
| K872875 | STRETCH GAUZE BANDAGES | Sep 4, 1987 | Substantially Equivalent |
| K872874 | MICROSCOPE COVER GLASSES | Aug 10, 1987 | Substantially Equivalent |
| K872797 | NON-SKID SHOE COVERS | Aug 4, 1987 | Substantially Equivalent |
| K871465 | THERMOMETER SHEATHS | May 11, 1987 | Substantially Equivalent |
| K862726 | DISPOSABLE SHOE COVERS AND NURSES CAPS | Aug 1, 1986 | Substantially Equivalent |
| K862111 | ARMBOARDS, REUSABLE AND DISPOSABLE | Jul 8, 1986 | Substantially Equivalent |