FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BLACK BAG, ELECTRONIC
K Number: K780023
·
Decision Feb 21, 1978
Classifications
1
FEI Numbers
180
Registration Numbers
180
Same Product Code
27
Applicant Total
3
Review Days
48
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Basic Information
- Device Name
- BLACK BAG, ELECTRONIC
- K Number
- K780023
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 870.1875
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Marshall Electronics, Inc.
- Date Received
- January 4, 1978
- Decision Date
- February 21, 1978
- 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 |
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