Card Guard
FDA 510(k) K934795 · Card Guard Scientific Survival , Ltd.
510(k) numberK934795
Submission
- Device name
- Card Guard
- Applicant
- Card Guard Scientific Survival , Ltd.
Rockville, MD, US - Received
- October 6, 1993
- Decision date
- April 14, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BZH – Meter, Peak Flow, Spirometry
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1860
- Specialty
- Anesthesiology
Other 510(k)s with product code BZH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253180 | Microlife Digital Peak Flow Meter, Model PF200B (PF200B)BZH · Traditional | Microlife Corporation | 06/23/2026SE |
| K252802 | Peak Flow Meter (PF-10(BR-PEF231))BZH · Traditional | Shenzhen Bi-Rich Medical Devices Co., Ltd. | 05/29/2026SE |
| K241338 | Peak Flow MeterBZH · Traditional | Chongqing Moffy Innovation Technology Co., Ltd. | 12/31/2024SE |
| K232588 | Aluna 2BZH · Traditional | Knox Medical Diagnostics | 11/25/2024SE |
| K230423 | Electronic Peak Flow MeterBZH · Traditional | Taian Dalu Medical Instrument Co., Ltd. | 02/23/2024SE |
| K222810 | TD-7301 Peak Flow meterBZH · Traditional | Gostar Co., Ltd. | 12/19/2023SE |
| K203196 | Peak flow meterBZH · Traditional | Shanghai Sonmol Medical Equipment Co., Ltd. | 05/26/2021SE |
| K200832 | Safey Peak Flow MeterBZH · Traditional | Safey Medical Devices Pvt, Ltd. | 07/30/2020SE |
| K193311 | AlunaBZH · Traditional | Knox Medical Diagnostics, Inc. | 03/25/2020SE |
| K191239 | Smart Peak Flow MeterBZH · Traditional | Guangzhou Homesun Medical Technology Co., Ltd. | 12/06/2019SE |
More from Guangzhou Homesun Medical Technology Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K111745 | King of Hearts Express Af Cardiac Event RecorderDSH · Special | 08/01/2011SE |
| K110499 | CG-5108 ACT-3L Continuous ECG Monitor and Arrhythmia DetectorDSI · Special | 04/06/2011SE |
| K101703 | Modification to: CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector, Model…DSI · Special | 07/13/2010SE |
| K101639 | CG-6108 Act-Il Continuous ECG Monitor and Arrythmia DetectorDSI · Special | 06/25/2010SE |
| K083174 | HealthepodDXH · Traditional | 12/17/2009SE |
| K082521 | EASY2CHECK Blood Glucose and Blood Pressure Monitoring SystemNBW · Traditional | 01/16/2009SE |
| K081257 | CG-6108 ACT-3L Continuous ECG Monitor & Arrhythmia DetectorDSI · Special | 05/29/2008SE |
| K071995 | CG-6108 Continuous ECG Monitor and Arrhythmia DetectorDSI · Traditional | 12/18/2007SE |
| K061428 | PMP4 ApplicationMSX · Traditional | 10/16/2006SE |
| K061528 | Selfcheck GlucoCGA · Traditional | 09/22/2006SE |
Questions and answers
When was Card Guard cleared by the FDA?
Card Guard (K934795) received a 510(k) decision of Substantially Equivalent on April 14, 1995, 555 days after the submission was received.
What is the product code of K934795?
The FDA product code is BZH – Meter, Peak Flow, Spirometry, a Class II (moderate risk) device regulated under 21 CFR 868.1860.