Lifecare Remote Alarm #34-001
FDA 510(k) K862212 · Lifecare Services, Inc.
510(k) numberK862212
Submission
- Device name
- Lifecare Remote Alarm #34-001
- Applicant
- Lifecare Services, Inc.
Boulder, CO, US - Received
- June 10, 1986
- Decision date
- June 23, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CBK – Ventilator, Continuous, Facility Use
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5895
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
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|---|---|---|---|
| K253647 | Evita (V800); Evita (V600)CBK · Traditional | Draegerwerk AG & CO Kgaa | 05/07/2026SE |
| K252663 | Inbentus VersatileCBK · Traditional | Iconic Solutions by Murcia, SL | 04/14/2026SE |
| K251888 | VPAP Pediatric Face MaskCBK · Traditional | Hsiner Co., Ltd. | 03/12/2026SE |
| K232365 | Vivo 45 LSCBK · Traditional | Oconnell Regulatory Consultants, Inc. | 12/19/2025SE |
| K252173 | F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size A…CBK · Traditional | Fisher & Paykel Healthcare, Ltd. | 09/10/2025SE |
| K243767 | SV600, SV800 VentilatorCBK · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 08/28/2025SE |
| K251133 | AVEA disposable expiratory filter/water trap (11790)CBK · Traditional | Telesair, Inc. | 05/08/2025SE |
| K243394 | AF531 Oro-Nasal SE Face MaskCBK · Traditional | Respironics, Inc. | 12/30/2024SE |
| K233486 | 731 Series VentilatorCBK · Traditional | ZOLL Medical Corporation | 12/13/2024SE |
| K223120 | Ventoux VC2; Ventoux VC3CBK · Traditional | Flight Medical Innovations , Ltd. | 12/02/2024SE |
More from Flight Medical Innovations , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| 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 |
| 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 Remote Alarm #34-001 cleared by the FDA?
Lifecare Remote Alarm #34-001 (K862212) received a 510(k) decision of Substantially Equivalent on June 23, 1986, 13 days after the submission was received.
What is the product code of K862212?
The FDA product code is CBK – Ventilator, Continuous, Facility Use, a Class II (moderate risk) device regulated under 21 CFR 868.5895.