Freeway Nebulizer Compressor
FDA 510(k) K895592 · Lifecare Services, Inc.
510(k) numberK895592
Submission
- Device name
- Freeway Nebulizer Compressor
- Applicant
- Lifecare Services, Inc.
Lafayette, CO, US - Received
- September 15, 1989
- Decision date
- November 21, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CCQ – Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.5640
- Specialty
- Anesthesiology
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More from Medical Industries America, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K913423 | Lifecare Remote Alarm IICBK · Traditional | 01/30/1992SE |
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| K910947 | NEV-10 Negative Pressure VentilatorBYT · Traditional | 06/03/1991SE |
| K894779 | Lifecare Nasal Mask Kit Cat. No. 06-800BYE · Traditional | 01/12/1990SE |
| 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 |
| K832467 | Portable Lifecare Ventilator PLV-100CBK · Traditional | 10/20/1983SE |
Questions and answers
When was Freeway Nebulizer Compressor cleared by the FDA?
Freeway Nebulizer Compressor (K895592) received a 510(k) decision of Substantially Equivalent on November 21, 1989, 67 days after the submission was received.
What is the product code of K895592?
The FDA product code is CCQ – Nebulizer, Medicinal, Non-Ventilatory (Atomizer), a Class I (low risk) device regulated under 21 CFR 868.5640.