Lifecare Nasal Mask Kit Cat. No. 06-800
FDA 510(k) K894779 · Lifecare Services, Inc.
510(k) numberK894779
Submission
- Device name
- Lifecare Nasal Mask Kit Cat. No. 06-800
- Applicant
- Lifecare Services, Inc.
Lafayette, CO, US - Received
- July 27, 1989
- Decision date
- January 12, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BYE – Attachment, Breathing, Positive End Expiratory Pressure
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5965
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
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More from A Plus Medical
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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 |
| 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 |
| K832467 | Portable Lifecare Ventilator PLV-100CBK · Traditional | 10/20/1983SE |
Questions and answers
When was Lifecare Nasal Mask Kit Cat. No. 06-800 cleared by the FDA?
Lifecare Nasal Mask Kit Cat. No. 06-800 (K894779) received a 510(k) decision of Substantially Equivalent on January 12, 1990, 169 days after the submission was received.
What is the product code of K894779?
The FDA product code is BYE – Attachment, Breathing, Positive End Expiratory Pressure, a Class II (moderate risk) device regulated under 21 CFR 868.5965.