FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LEFF STETHOSCOPE FOR FETAL HEART
K Number: K761338
·
Decision Jan 12, 1977
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
1
Applicant Total
18
Review Days
16
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Basic Information
- Device Name
- LEFF STETHOSCOPE FOR FETAL HEART
- K Number
- K761338
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 884.2900
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- J. Sklar Mfg. Co., Inc.
- Date Received
- December 27, 1976
- Decision Date
- January 12, 1977
- Product Code
- HGN
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| HGN | Stethoscope, Fetal | FDA class 1 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HGN), ordered by most recent decision date.
View allOther Clearances by J. Sklar Mfg. Co., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K843693 | JACOBS HIGH VACUUM SUCTION UNIT 05-2570 | Oct 31, 1984 | Substantially Equivalent |
| K842112 | TISCHLER CERVICAL BIOPSY PUNCH FORCEPS | Jul 3, 1984 | Substantially Equivalent |
| K842111 | KOGAN ENDOSPECULUM 9-1/2 | Jun 19, 1984 | Substantially Equivalent |
| K822448 | SCISSORS, VARIOUS | Sep 14, 1982 | Substantially Equivalent |
| K802457 | KEVORKIAN-YOUNGE BIOPSY PUNCH, #90-6610 | Jan 12, 1981 | Substantially Equivalent |
| K802458 | KEVORKIAN-YOUNGE BIOPSY CURETTE #90-6611 | Jan 12, 1981 | Substantially Equivalent |
| K801273 | MAGILL CATHETER INTRO. FORCEPS | Jul 28, 1980 | Substantially Equivalent |
| K800441 | RUDD-CLINIC HEMORRHOIDAL FORCEPS | Apr 8, 1980 | Substantially Equivalent |
| K790577 | HEMORRHOIDAL LIGATOR | Apr 23, 1979 | Substantially Equivalent |
| K772230 | CANNULA, PERFUSION, FALLOPIAN TUBE | Jan 3, 1978 | Substantially Equivalent |