FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
STETH-SHIELD ACCESSORY TO A STETHOSCOPE
K Number: K882324
·
Decision Jul 18, 1988
Classifications
1
FEI Numbers
180
Registration Numbers
180
Same Product Code
27
Applicant Total
1
Review Days
42
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- STETH-SHIELD ACCESSORY TO A STETHOSCOPE
- K Number
- K882324
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 870.1875
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Steth-Shield, Inc.
- Date Received
- June 6, 1988
- Decision Date
- July 18, 1988
- 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
Other 510(k) clearances with the same product code (LDE), ordered by most recent decision date.
CYPRESS MEDICAL PRODUCTS STETHOSCOPE
FDA 510(k)
FDA Class 1
·Cardiovascular
VARIOUS STETHOSCOPES
FDA 510(k)
FDA Class 1
·Cardiovascular
MANUAL STETOSCOPE
FDA 510(k)
FDA Class 1
·Cardiovascular
PROSCOPES AND ADSCOPES
FDA 510(k)
FDA Class 1
·Cardiovascular
STETHOSCOPE COVER
FDA 510(k)
FDA Class 1
·Cardiovascular
TIMEOSCOPE AND FLEXISCOPE
FDA 510(k)
FDA Class 1
·Cardiovascular