510(k) K850538
- Device
- BED SENTRY, MODEL 50U
- Applicant
- METATECH CORP.
- 510(k) number
- K850538
- Product code
- KPN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-04-03
- Date received
- 1985-02-11
- Regulation
- 876.2040
- Classification name
- Alarm, Conditioned Response Enuresis
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- WIDNER
- Address
- 203 Westbrook Dr. Austin TX US 78746 78746
FDA Registration Numbers#
- 3018240701
- 3005555608
- 3003952845
- 3017133271
- 3005739654
- 3010540632
- 3010162782
- 3012375800
- 9710120
- 3008175374
- 1417592
- 3014926187
- 3035544212
- 9613434
- 3004436821
- 1051594
- 3016761372
- 3010177964
- 9615478
- 8030877
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KPN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K130951 | SIM | Simavita Pty Limited | 2013-08-22 |
| K971442 | 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 | Humed, Inc. | 1998-01-08 |
| K971855 | POTTY PAL AND FOREVER-DRY | Digital Applications, Inc. | 1997-08-18 |
| K962770 | UROSURGE ACUTRAINER | Princeton Regulatory Assoc. | 1996-08-01 |
| K962416 | DRYTIME FOR BLADDER CONTROL SILENT | Bio-Systems Research | 1996-07-22 |
| K955338 | DRYTIME FOR POTTY TRAINING | Health Sense Intl., Inc. | 1996-03-12 |
| K943559 | REMOTE A'LERT | Health Sense Intl., Inc. | 1995-05-24 |
| K943558 | PRO'TECT | Health Sense Intl., Inc. | 1995-05-24 |
| K942057 | FISHER-PRICE DRY NIGHT MONITOR | Fisher Price | 1994-07-28 |
| K935915 | WET SENSE | Edson Corp. | 1994-05-13 |
| K934369 | DRI SLEEPER | Laborie Medical Technologies, Ltd. | 1993-11-24 |
| K930005 | DRITRAINER | Laborie Medical Technologies, Ltd. | 1993-03-03 |
| K921431 | POTTY PAGER | Ideas For Living | 1992-07-21 |
| K911279 | DRY TIME | Health Sense Intl., Inc. | 1991-09-04 |
| K903856 | WET-NO-MORE MONITOR | Travis Industries, Inc. | 1990-09-12 |
Legacy Summary#
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FDA Review#
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