HOSPITAL/HOME ENVIRONMENTAL CONTROL SYST/HECS-1
FDA 510(k) clearance K902664 · decided 1990-07-25
Clearance details
- K-number
- K902664
- Device name
- HOSPITAL/HOME ENVIRONMENTAL CONTROL SYST/HECS-1
- Applicant
- Prentke Romich Co.
- Decision
- Substantially Equivalent
- Date received
- 1990-06-18
- Decision date
- 1990-07-25
- Days to decision
- 37 days
- Clearance type
- Traditional
- Product code
- IQA
- Device class
- 2
- Regulation number
- 890.3725
- 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 |
|---|---|---|
| DELTATALKER WITH INFRARED (K961306) | Prentke Romich Co. | 1996-06-27 |
| IMPERIUM (K953905) | Teledyne Brown Engineering | 1995-11-21 |
| LIAISON COMPUTER ACCESS & ENVIRONMENTAL CONTROL SYSTEM (K953937) | Apt Technology, Inc. | 1995-10-31 |
| DEUCE (K943244) | Apt Technology, Inc. | 1995-09-11 |
| SCANNING DIRECTOR (K944585) | Prentke Romich Co. | 1995-02-21 |
| BEDSIDE BUTLER (K944345) | Trac Medical, Inc. | 1994-10-17 |
| LEARN MODE WATERPROOF PENDANT PANIC BUTTON (K940223) | Interactive Technologies, Inc. | 1994-04-29 |
| INFRA-LINK (K926029) | Zygo Industries, Inc. | 1993-03-26 |
| HILL-ROM PATIENT ENVIRONMENTAL CONTROL SYSTEM (K921528) | Hill-Rom, Inc. | 1992-04-20 |
| TONGUETOUCH KEYPAD AND ZOFCOM CONTROL SYSTEM (K911101) | Zofcom, Inc. | 1991-04-25 |
| ENVIRONMENTAL CONTROL UNIT MODEL 7000 (K901028) | Baylor Biomedical Services | 1990-03-13 |
| REMOTE CONTROL SWITCH (K900969) | Baylor Biomedical Services | 1990-03-13 |
Recalls involving this device
No recalls on record reference this clearance.