Biolog
FDA 510(k) K895534 · Micromedical
510(k) numberK895534
Submission
- Device name
- Biolog
- Applicant
- Micromedical
Gettysburg, PA, US - Received
- September 13, 1989
- Decision date
- March 19, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DRT – Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2300
- Specialty
- Cardiovascular
Other 510(k)s with product code DRT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261286 | The Circadia C300 System (C300)DRT · Special | Circadia Health, Inc. | 05/20/2026SE |
| K252676 | The Circadia C300 System (C300)DRT · Traditional | Circadia Health, Inc. | 02/03/2026SE |
| K253388 | Sleepiz One+ (Model 2.5)DRT · Special | Sleepiz AG | 01/28/2026SE |
| K251364 | Sleepiz One+ (2.5)DRT · Special | Sleepiz AG | 07/29/2025SE |
| K234003 | The Circadia C200 SystemDRT · Traditional | Circadia Technologies, Ltd. | 05/30/2024SE |
| K232354 | Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server…DRT · Traditional | Murata Vios, Inc. | 03/22/2024SE |
| K231733 | Neteera 130H-Plus Vital Sign Monitoring SensorDRT · Traditional | Neteera Technologies , Ltd. | 02/09/2024SE |
| K223163 | Sleepiz One+DRT · Traditional | Sleepiz AG | 08/18/2023SE |
| K212143 | Neteera 130H/131H Vital Sign Monitoring SensorDRT · Traditional | Neteera Technologies , Ltd. | 09/28/2022SE |
| K202138 | Cardiac Trigger MonitorDRT · Traditional | Ivy Biomedical Systems, Inc. | 05/14/2021SE |
More from Ivy Biomedical Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K974352 | Cardioview 3000 SoftwareLOS · Traditional | 09/08/1998SE |
| K974220 | Micromedical 12 Lead Simultaneous CableDPS · Traditional | 08/25/1998SE |
| K974351 | Biolog 3000 ElectrocardiographDPS · Traditional | 04/01/1998SE |
| K970305 | Printer InterfaceDXH · Traditional | 08/15/1997SE |
| K955891 | Cardioview Transtelephonic SoftwareDPS · Traditional | 10/08/1996SE |
| K895535 | PaceviewKRE · Traditional | 03/19/1990SE |
Questions and answers
When was Biolog cleared by the FDA?
Biolog (K895534) received a 510(k) decision of Substantially Equivalent on March 19, 1990, 187 days after the submission was received.
What is the product code of K895534?
The FDA product code is DRT – Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), a Class II (moderate risk) device regulated under 21 CFR 870.2300.