FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ELITE BIOFEEDBACK
K Number: K942563
·
Decision Jun 6, 1995
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
64
Applicant Total
11
Review Days
371
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Basic Information
- Device Name
- ELITE BIOFEEDBACK
- K Number
- K942563
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.1425
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Laborie Medical Technologies, Ltd.
- Date Received
- May 31, 1994
- Decision Date
- June 6, 1995
- Product Code
- HIR
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| HIR | Perineometer | FDA class 2 | Obstetrics/Gynecology |
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Other Clearances by Laborie Medical Technologies, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K090830 | LABORIE INJETAK ADJUSTABLE TIP NEEDLE, FLEXIBLE TIP AND RIDGID TIP | Jul 21, 2009 | Substantially Equivalent |
| K962009 | UROSTYM | May 20, 1997 | Substantially Equivalent |
| K955856 | TEX-AID BLUE | Feb 16, 1996 | Substantially Equivalent |
| K955810 | U-TEX | Jan 24, 1996 | Substantially Equivalent |
| K951805 | PIPER, MODEL NUMBER UDS-PIPERB | Jul 6, 1995 | Substantially Equivalent |
| K942023 | INFUSION PUMP, MODEL NO. UDP-5 | Jul 12, 1994 | Substantially Equivalent |
| K934369 | DRI SLEEPER | Nov 24, 1993 | Substantially Equivalent |
| K931574 | ADVANCE MODEL UDS-ADV | Aug 5, 1993 | Substantially Equivalent |
| K930005 | DRITRAINER | Mar 3, 1993 | Substantially Equivalent |
| K924086 | NICKI, MODEL NUMBER USD-NK-UP1 | Oct 20, 1992 | Substantially Equivalent |