TELEPULSE— 510(k) K925040
Substantially EquivalentBiometrix , Ltd.
FDA 510(k) clearance K925040 for TELEPULSE, Substantially Equivalent on 1993-08-23. Applicant: Biometrix , Ltd.. Device class: 2.
Clearance details
- Applicant
- Biometrix , Ltd.
- Product code
- Code JEH
- Device class
- Class 2
- Regulation
- 21 CFR 868.1760
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Greenwich, CT, US
Recent devices under product code JEH
view allMore clearances from Biometrix , Ltd.
view all- K151040 — Art-line Single channel blood pressure system, Art-line Double channel blood pressure system, Art-line Triple channel blood pressure system, IAP Monitoring Set with Disposable Transducer
- K011216 — PVC FREE INTRAVASCULAR ADMINISTRATION SET
- K001461 — TPN NUTRITION BAG (EVA), EMPTYING TUBE, BAG SYRINGE FILL SET
Data sourced from openFDA. This site is unofficial and independent of the FDA.