Mortara Instrument Model Eli 50
FDA 510(k) K902652 · Mortara Instrument, Inc.
510(k) numberK902652
Submission
- Device name
- Mortara Instrument Model Eli 50
- Applicant
- Mortara Instrument, Inc.
Milwaukee, WI, US - Received
- June 15, 1990
- Decision date
- August 23, 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
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| K202138 | Cardiac Trigger MonitorDRT · Traditional | Ivy Biomedical Systems, Inc. | 05/14/2021SE |
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Questions and answers
When was Mortara Instrument Model Eli 50 cleared by the FDA?
Mortara Instrument Model Eli 50 (K902652) received a 510(k) decision of Substantially Equivalent on August 23, 1990, 69 days after the submission was received.
What is the product code of K902652?
The FDA product code is DRT – Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), a Class II (moderate risk) device regulated under 21 CFR 870.2300.