FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LITTMAN TYPE SH-6010, NURSE TYPE
K Number: K842203
·
Decision Jun 6, 1985
Classifications
1
FEI Numbers
180
Registration Numbers
180
Same Product Code
27
Applicant Total
7
Review Days
367
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Basic Information
- Device Name
- LITTMAN TYPE SH-6010, NURSE TYPE
- K Number
- K842203
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 870.1875
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Cher Mel Corp.
- Date Received
- June 4, 1984
- Decision Date
- June 6, 1985
- 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
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VARIOUS STETHOSCOPES
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MANUAL STETOSCOPE
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PROSCOPES AND ADSCOPES
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STETHOSCOPE COVER
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TIMEOSCOPE AND FLEXISCOPE
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Other Clearances by Cher Mel Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K863040 | DISPOSABLE INTRAVENOUS HYPERALIMENTATION BAGS | Oct 31, 1986 | Substantially Equivalent |
| K851516 | CHERMEL SCALP VEIN SET | Aug 23, 1985 | Substantially Equivalent |
| K843324 | SPRAGUE RAPPAPORT/SH-6008 DISPOS. STETH | Jun 6, 1985 | Substantially Equivalent |
| K842822 | CHERMEL BONE GOUGES | Aug 2, 1984 | Substantially Equivalent |
| K842823 | CHERMEL OSTEOTOMES | Aug 2, 1984 | Substantially Equivalent |
| K842824 | CHERMEL BONE CHISELS | Aug 2, 1984 | Substantially Equivalent |