Bio-Med Corp. Disp. Non-sterile Transducer
510(k) K801985
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK801985 | Date9 Sep 1980 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Bio-Med Corp. Disp. Non-Sterile Transdu
- 510(k) Number
- FDA Product Code
- DRS
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2850
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 24 Sep 2026
The device is a non‑sterile blood‑pressure extravascular transducer intended for cardiovascular measurement. It is classified as a Class II device under product code DRS and is identified as a transducer for blood‑pressure applications in the FDA’s device nomenclature.
The transducer is supplied non‑sterile by Bio‑Med Corp. and received FDA 510(k) clearance (K801985) on 9 September 1980 with a decision of substantially equivalent. It is a reusable component intended for use in cardiovascular settings, and it is regulated under regulation number 870.2850.
Other devices from Bio-Med Corp.
Questions
AI-generated answers, 24 Sep 2026
What is the Bio-Med Corp. non-sterile transducer used for?
It is a reusable extravascular transducer intended for cardiovascular blood-pressure measurement.
Is the device sterile?
No, the device is supplied non-sterile by Bio-Med Corp.
How is the device regulated?
It is a Class II device that received FDA 510(k) clearance (K801985) on September 9, 1980.