Pulse Biomedical, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Pulse Biomedical, Inc. makes
Pulse Biomedical, Inc. manufactures cardiac monitoring systems focused on QRS complex and ST-segment analysis. Their products include standalone patient monitors with USB connectivity, as well as software suites designed for cardiology workflows. These devices are intended for real-time ECG monitoring and diagnostic support in clinical settings.
The company’s portfolio consists of Class II medical devices, regulated under the FDA’s 510(k) clearance pathway. These products are listed in the FDA’s 510(k) database. The manufacturer is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Qrs-Card Cardiology Suite Ref K042799
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Pulse Biomedical, Inc., initiated on 2007-03-05. By recorded status: 1 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2007
- 5 Mar 2007 Z-0716-2007 Unclassified (pre-2012) Terminated No 510(k) marketing clearance for the product
Full distribution text
- 5 Mar 2007 Z-0716-2007 Unclassified (pre-2012) Terminated No 510(k) marketing clearance for the product
Frequently asked questions
How many devices does Pulse Biomedical, Inc. have in the registry?
The registry currently lists 3 devices for Pulse Biomedical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Pulse Biomedical, Inc.'s devices?
Among its 3 most recently registered devices, Pulse Biomedical, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Pulse Biomedical, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Pulse Biomedical, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Pulse Biomedical, Inc.?
FDA recall records list 1 recall initiated by Pulse Biomedical, Inc., the most recent initiated on 5 Mar 2007. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Pulse Biomedical, Inc. in the registry?
The most recently registered devices listed for Pulse Biomedical, Inc. include PULSE BIOMEDICAL INC, QRS CARD S-T SEGMENT ANALYSIS MONITORING SYSTEM, QRS CARD S-T SEGMENT ANALYSIS PATIENT MONITORING SYSTEM MODEL: QRS CARD USB and QRS-CARD CARDIOLOGY SUITE.