LIGHT TALKER
FDA 510(k) clearance K925527 · decided 1993-03-22
Clearance details
- K-number
- K925527
- Device name
- LIGHT TALKER
- Applicant
- Prentke Romich Co.
- Decision
- Substantially Equivalent
- Date received
- 1992-11-02
- Decision date
- 1993-03-22
- Days to decision
- 140 days
- Clearance type
- Traditional
- Product code
- ILQ
- Device class
- 2
- Regulation number
- 890.3710
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Wooster, OH, 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 |
|---|---|---|
| Noddle(TM) (K162817) | Iowa Adaptive Technologies, Inc. Dba Voxello, Inc. | 2017-01-18 |
| P.A.T. SYSTEM (K943035) | Mathews Assoc., Inc. | 1994-10-04 |
| COMFORT KEYBOARD SYSTEM (K930044) | Health Care Keyboard Co., Inc. | 1994-07-14 |
| LIGHTWRITER (K931855) | Zygo Corp. | 1994-05-10 |
| R & D BATTERIES, INC. PART NUMBER 5113 (K935244) | R & D Batteries, Inc. | 1994-04-19 |
| MLT-2 (K935981) | Med Labs, Inc. | 1994-02-17 |
| LIBERATOR (K925387) | Prentke Romich Co. | 1993-03-29 |
| SCRIBE (K924030) | Zygo Industries, Inc. | 1993-03-04 |
| SECRETARY (K924014) | Zygo Industries, Inc. | 1993-03-04 |
| PARROT (K924015) | Zygo Industries, Inc. | 1993-03-04 |
| MACAW (K924013) | Zygo Industries, Inc. | 1993-03-04 |
| EEC-1 PACKAGE (K923819) | Med Labs, Inc. | 1992-11-06 |
Recalls involving this device
No recalls on record reference this clearance.