FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
VARIOUS TYPES OF STETHOSCOPES
K Number: K905487
·
Decision Apr 9, 1991
Classifications
1
FEI Numbers
180
Registration Numbers
180
Same Product Code
27
Applicant Total
6
Review Days
124
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Basic Information
- Device Name
- VARIOUS TYPES OF STETHOSCOPES
- K Number
- K905487
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 870.1875
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Liaoning-Usa Corp.
- Date Received
- December 6, 1990
- Decision Date
- April 9, 1991
- Product Code
- LDE
- 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 |
|---|---|---|---|
| LDE | Stethoscope, Manual | FDA class 1 | Cardiovascular |
Similar 510(k) Clearances
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TIMEOSCOPE AND FLEXISCOPE
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Other Clearances by Liaoning-Usa Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K911921 | DISPOSABLE ISOLATION GOWN | May 13, 1991 | Substantially Equivalent |
| K910623 | GAUZE SPONGES ABSORBENT GAUZE ROLLS | Apr 1, 1991 | Substantially Equivalent |
| K902625 | CLINICAL THERMOMETER; RECTAL/ORAL, INNER ARMPIT | Oct 26, 1990 | Substantially Equivalent |
| K892781 | ANTELOPE BRAND PATIENT EXAMINATION GLOVES | Sep 21, 1989 | Substantially Equivalent |
| K892774 | PATIENT EXAMINATION GLOVES | Sep 13, 1989 | Substantially Equivalent |