Lionheart 3 Multi-Parameter Simulator
FDA 510(k) K944257 · Bio-Tek Instruments, Inc.
510(k) numberK944257
Submission
- Device name
- Lionheart 3 Multi-Parameter Simulator
- Applicant
- Bio-Tek Instruments, Inc.
Winooski, VT, US - Received
- August 31, 1994
- Decision date
- September 21, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DRT – Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2300
- Specialty
- Cardiovascular
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Questions and answers
When was Lionheart 3 Multi-Parameter Simulator cleared by the FDA?
Lionheart 3 Multi-Parameter Simulator (K944257) received a 510(k) decision of Substantially Equivalent on September 21, 1994, 21 days after the submission was received.
What is the product code of K944257?
The FDA product code is DRT – Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), a Class II (moderate risk) device regulated under 21 CFR 870.2300.