FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
DRI SLEEPER
K Number: K934369
·
Decision Nov 24, 1993
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
36
Applicant Total
11
Review Days
78
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- DRI SLEEPER
- K Number
- K934369
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.2040
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Laborie Medical Technologies, Ltd.
- Date Received
- September 7, 1993
- Decision Date
- November 24, 1993
- Product Code
- KPN
- Advisory Committee
- Gastroenterology, Urology
- 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 |
|---|---|---|---|
| KPN | Alarm, Conditioned Response Enuresis | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KPN), ordered by most recent decision date.
SIM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HUGHES BLADDER AND BOWEL TRAINING SYSTEM(AD-T-18, MED-18,MED-1,MED-T-1,MEDD-18,MED-38,MED-T-10,MED-T-25,MED-T-5
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
POTTY PAL AND FOREVER-DRY
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
UROSURGE ACUTRAINER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DRYTIME FOR BLADDER CONTROL SILENT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DRYTIME FOR POTTY TRAINING
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
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 |
| K942563 | ELITE BIOFEEDBACK | Jun 6, 1995 | Substantially Equivalent |
| K942023 | INFUSION PUMP, MODEL NO. UDP-5 | Jul 12, 1994 | 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 |