6-415 Filter, Element, 170-C
FDA 510(k) K802925 · Lifecare Services, Inc.
510(k) numberK802925
Submission
- Device name
- 6-415 Filter, Element, 170-C
- Applicant
- Lifecare Services, Inc.
Mchenry, IL, US - Received
- November 19, 1980
- Decision date
- December 19, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DSK – Computer, Blood-Pressure
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1110
- Specialty
- Cardiovascular
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|---|---|---|
| K913423 | Lifecare Remote Alarm IICBK · Traditional | 01/30/1992SE |
| K912224 | Lifecare CPAP-100BZD · Traditional | 09/23/1991SE |
| K910947 | NEV-10 Negative Pressure VentilatorBYT · Traditional | 06/03/1991SE |
| K894779 | Lifecare Nasal Mask Kit Cat. No. 06-800BYE · Traditional | 01/12/1990SE |
| K895592 | Freeway Nebulizer CompressorCCQ · Traditional | 11/21/1989SE |
| K894361 | Lifecare Pressure Alarm Cat. No. 34-010CAP · Traditional | 10/05/1989SE |
| K880378 | Lota, Lifecare Oxygen/Temperature Analyzer 36-001CCL · Traditional | 09/30/1988SE |
| K873570 | Lifecare Exhalation Valve #06-699CBP · Traditional | 11/30/1987SE |
| K862212 | Lifecare Remote Alarm #34-001CBK · Traditional | 06/23/1986SE |
| K842876 | Portable Lifecare Ventilator PLV-102CBK · Traditional | 08/29/1984SE |
Questions and answers
When was 6-415 Filter, Element, 170-C cleared by the FDA?
6-415 Filter, Element, 170-C (K802925) received a 510(k) decision of Substantially Equivalent on December 19, 1980, 30 days after the submission was received.
What is the product code of K802925?
The FDA product code is DSK – Computer, Blood-Pressure, a Class II (moderate risk) device regulated under 21 CFR 870.1110.