Infra-Link
FDA 510(k) K926029 · Zygo Industries, Inc.
510(k) numberK926029
Submission
- Device name
- Infra-Link
- Applicant
- Zygo Industries, Inc.
Portland, OR, US - Received
- December 1, 1992
- Decision date
- March 26, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- IQA – System, Environmental Control, Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.3725
- Specialty
- Physical Medicine
Other 510(k)s with product code IQA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K961306 | Deltatalker with InfraredIQA · Traditional | Prentke Romich Co. | 06/27/1996SE |
| K953905 | ImperiumIQA · Traditional | Teledyne Brown Engineering | 11/21/1995SE |
| K953937 | Liaison Computer Access & Environmental Control SystemIQA · Traditional | Apt Technology, Inc. | 10/31/1995SE |
| K943244 | DeuceIQA · Traditional | Apt Technology, Inc. | 09/11/1995SE |
| K944585 | Scanning DirectorIQA · Traditional | Prentke Romich Co. | 02/21/1995SE |
| K944345 | Bedside ButlerIQA · Traditional | Trac Medical, Inc. | 10/17/1994SE |
| K940223 | Learn Mode Waterproof Pendant Panic ButtonIQA · Traditional | Interactive Technologies, Inc. | 04/29/1994SE |
| K921528 | Hill-Rom Patient Environmental Control SystemIQA · Traditional | Hill-Rom, Inc. | 04/20/1992SE |
| K911101 | Tonguetouch Keypad and Zofcom Control SystemIQA · Traditional | Zofcom, Inc. | 04/25/1991SE |
| K902664 | Hospital/Home Environmental Control SYST/HECS-1IQA · Traditional | Prentke Romich Co. | 07/25/1990SE |
More from Prentke Romich Co.
Questions and answers
When was Infra-Link cleared by the FDA?
Infra-Link (K926029) received a 510(k) decision of Substantially Equivalent on March 26, 1993, 115 days after the submission was received.
What is the product code of K926029?
The FDA product code is IQA – System, Environmental Control, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.3725.