NIGHT TRAINER
FDA 510(k) clearance K834311 · decided 1984-03-30
Clearance details
- K-number
- K834311
- Device name
- NIGHT TRAINER
- Applicant
- Maddak, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-11-25
- Decision date
- 1984-03-30
- Days to decision
- 126 days
- Clearance type
- Traditional
- Product code
- KPN
- Device class
- 2
- Regulation number
- 876.2040
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SIM (K130951) | Simavita Pty Limited | 2013-08-22 |
| 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 (K971442) | Humed, Inc. | 1998-01-08 |
| POTTY PAL AND FOREVER-DRY (K971855) | Digital Applications, Inc. | 1997-08-18 |
| UROSURGE ACUTRAINER (K962770) | Princeton Regulatory Assoc. | 1996-08-01 |
| DRYTIME FOR BLADDER CONTROL SILENT (K962416) | Bio-Systems Research | 1996-07-22 |
| DRYTIME FOR POTTY TRAINING (K955338) | Health Sense Intl., Inc. | 1996-03-12 |
| PRO'TECT (K943558) | Health Sense Intl., Inc. | 1995-05-24 |
| REMOTE A'LERT (K943559) | Health Sense Intl., Inc. | 1995-05-24 |
| FISHER-PRICE DRY NIGHT MONITOR (K942057) | Fisher Price | 1994-07-28 |
| WET SENSE (K935915) | Edson Corp. | 1994-05-13 |
| DRI SLEEPER (K934369) | Laborie Medical Technologies, Ltd. | 1993-11-24 |
| DRITRAINER (K930005) | Laborie Medical Technologies, Ltd. | 1993-03-03 |
Recalls involving this device
No recalls on record reference this clearance.