FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OP3/VP4
K Number: K924516
·
Decision Jun 28, 1993
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
35
Applicant Total
23
Review Days
297
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Basic Information
- Device Name
- OP3/VP4
- K Number
- K924516
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.2960
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Huntleigh Technology, Inc.
- Date Received
- September 4, 1992
- Decision Date
- June 28, 1993
- Product Code
- HGL
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| HGL | Transducer, Ultrasonic, Obstetric | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HGL), ordered by most recent decision date.
ULTRASOUND TRANSDUCER, MODEL US917
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EUP-V12 5.0 MHZ CONVEX ARRAY TRANSVAGINAL PROBE
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ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCER
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MER MULTIPLANE VAGINAL PROBE (MVP)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Other Clearances by Huntleigh Technology, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K992733 | AKRON ATP9 TRACTION MACHINE | Nov 10, 1999 | Substantially Equivalent |
| K964699 | RHEO DOPPLEX II (RD 2) | Feb 21, 1997 | Substantially Equivalent |
| K910188 | FLOWPLUS AC330 PUMP GARMENTS | May 28, 1991 | Substantially Equivalent |
| K900882 | MULTI DOPPLEX, MD-1 | Aug 22, 1990 | Substantially Equivalent |
| K900618 | HUNTLEIGH FETAL DOPPLER, FD-1 & DOPCORD, D140 | Apr 25, 1990 | Substantially Equivalent |
| K890012 | HUNTLEIGH DYNAMIC FLOTATION SYSTEM | Mar 29, 1989 | Substantially Equivalent |
| K884451 | DOPCORD PPG | Jan 12, 1989 | Substantially Equivalent |
| K881632 | FLOWTRON DVT SYSTEM AC500 PUMP, L501 GARMENT | Sep 26, 1988 | Substantially Equivalent |
| K874688 | FLOWTRON AC200/2 | Sep 23, 1988 | Substantially Equivalent |
| K882644 | HUNTLEIGH DOUBLE BUBBLE AIR-O-PAD-AOP5 | Aug 10, 1988 | Substantially Equivalent |