FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BED SENTRY, MODEL 50U
K Number: K850538
·
Decision Apr 3, 1985
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
36
Applicant Total
13
Review Days
51
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
- BED SENTRY, MODEL 50U
- K Number
- K850538
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.2040
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Metatech Corp.
- Date Received
- February 11, 1985
- Decision Date
- April 3, 1985
- 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 Metatech Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K924314 | MOBILE STANDING FRAME | Feb 12, 1993 | Substantially Equivalent |
| K915370 | COPPER VAPOR LASER SYSTEM | Feb 7, 1992 | Substantially Equivalent |
| K903883 | VASCULASE(R) COPPER VAPOR LASER SYST, PIGMENT LES | Sep 19, 1990 | Substantially Equivalent |
| K890865 | HEXASCAN SCANNER HANDPIECE | Mar 24, 1989 | Substantially Equivalent |
| K883541 | METALASER VASCULASE | Nov 4, 1988 | Substantially Equivalent |
| K883881 | MODIFIED MODEL 2001 FIBER OPTICS CATHETER | Oct 27, 1988 | Substantially Equivalent |
| K883518 | EVENT MARKER & A SECOND PRESSURE TREND OUTPUT | Sep 22, 1988 | Substantially Equivalent |
| K882552 | METATECH ROBINSON BOLT ACCESSORY | Sep 8, 1988 | Substantially Equivalent |
| K882367 | METATECH MICROCLIP APPLICATOR | Aug 25, 1988 | Substantially Equivalent |
| K882286 | EXPANSION COUPLER & MANUAL DRILL AS ACCESSORY SET | Jul 18, 1988 | Substantially Equivalent |