510(k) K943035
- Device
- P.a.t. System
- Applicant
- MATHEWS ASSOC., INC.
- 510(k) number
- K943035
- Product code
- ILQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-10-04
- Date received
- 1994-06-27
- Regulation
- 890.3710
- Classification name
- System, Communication, Powered
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- DANIEL PERREAULT
- Address
- 645 Hickman Cir. Sanford FL US 32771 32771
FDA Registration Numbers#
- 2132111
- 3007728289
- 1122989
- 3023272766
- 3014653127
- 1320360
- 3014663624
- 3015185344
- 1526550
- 1528659
- 2950167
- 2026803
- 3010409478
- 3009879967
- 3007883990
- 1000125358
- 3004959902
- 3012616510
- 3009444092
- 3015437214
- 3005301283
- 3006141275
- 3006789226
- 3009591865
- 2027454
- 3013281419
- 3007729562
- 3005627440
- 3018783526
- 3001576173
- 3020018
- 3012964269
- 3010209365
- 3000126629
- 3010824482
- 3002713667
- 3029869534
- 3007275470
- 3031563240
- 3014315249
- 3009869586
- 3017237915
- 3008994998
- 3006891627
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code ILQ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K162817 | Noddle(TM) | Iowa Adaptive Technologies, Inc. Dba Voxello, Inc. | 2017-01-18 |
| K930044 | COMFORT KEYBOARD SYSTEM | Health Care Keyboard Co., Inc. | 1994-07-14 |
| K931855 | LIGHTWRITER | Zygo Corp. | 1994-05-10 |
| K935244 | R & D BATTERIES, INC. PART NUMBER 5113 | R & D Batteries, Inc. | 1994-04-19 |
| K935981 | MLT-2 | Med Labs, Inc. | 1994-02-17 |
| K925387 | LIBERATOR | Prentke Romich Co. | 1993-03-29 |
| K925527 | LIGHT TALKER | Prentke Romich Co. | 1993-03-22 |
| K924013 | MACAW | Zygo Industries, Inc. | 1993-03-04 |
| K924014 | SECRETARY | Zygo Industries, Inc. | 1993-03-04 |
| K924015 | PARROT | Zygo Industries, Inc. | 1993-03-04 |
| K924030 | SCRIBE | Zygo Industries, Inc. | 1993-03-04 |
| K923819 | EEC-1 PACKAGE | Med Labs, Inc. | 1992-11-06 |
| K914259 | TOUCH TALKER | Prentke Romich Co. | 1992-02-27 |
| K914103 | LIFELINE(R) PERSONAL RESPONSE SYSTEM | Lifeline Systems, Inc. | 1991-09-27 |
| K910819 | COMPANION SPEECH AID, MODEL 160 | Companion Products Intl. | 1991-03-07 |