SPEECH TEACHER
FDA 510(k) clearance K840112 · decided 1984-03-22
Clearance details
- K-number
- K840112
- Device name
- SPEECH TEACHER
- Applicant
- Joseph A. Resnick
- Decision
- Substantially Equivalent
- Date received
- 1984-01-09
- Decision date
- 1984-03-22
- Days to decision
- 73 days
- Clearance type
- Traditional
- Product code
- ILP
- Device class
- 1
- Regulation number
- 890.3700
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Joseph A. Resnick
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| TELL ME TAGS - NONPOWERED COMMUNICATION SYS (K844890) | Mina Manufacturers, Inc. | 1985-03-08 |
| ADAPTIVE PENS & LAP DESK (K831546) | Fred Sammons, Inc. | 1983-06-08 |
| MOUTH STICK KIT (K823625) | Fred Sammons, Inc. | 1982-12-30 |
| PICTURES & WORD IDENTIFICATION CVA PAT (K823608) | Fred Sammons, Inc. | 1982-12-30 |
| HOLDER FOR MOUTH STICK (K823624) | Fred Sammons, Inc. | 1982-12-30 |
| ADJ. WOODEN BOARD FOR WRITING (K823612) | Fred Sammons, Inc. | 1982-12-30 |
| KIT OF WORDS & LTRS TO RE-LEARN-BK4014 (K823609) | Fred Sammons, Inc. | 1982-12-22 |
| PLASTIC SLIP-ON PEN/PENCIL HOLDER (K823616) | Fred Sammons, Inc. | 1982-12-22 |
| FLEXIBLE HOLDER TO HOLD PHONE RECEIVER (K823614) | Fred Sammons, Inc. | 1982-12-22 |
| BK-4015 ECONOMY COMMUNICATION SHEET (K823610) | Fred Sammons, Inc. | 1982-12-22 |
| PLASTIC SLIP-ON POINTS W/RUBBER TIP FOR (K823617) | Fred Sammons, Inc. | 1982-12-22 |
| PLASTIC STOP TO HOLD TELEPHONE BUTTON (K823613) | Fred Sammons, Inc. | 1982-12-22 |
Recalls involving this device
No recalls on record reference this clearance.