Esis Module
FDA 510(k) K780043 · Datascope Corp.
510(k) numberK780043
Submission
- Device name
- Esis Module
- Applicant
- Datascope Corp.
Mchenry, IL, US - Received
- January 9, 1978
- Decision date
- February 13, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DRR – Amplifier And Signal Conditioner, Biopotential
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2050
- Specialty
- Cardiovascular
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| K874441 | Bard Biopotential AmplifierDRR · Traditional | C.R. Bard, Inc. | 01/19/1988SE |
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Questions and answers
When was Esis Module cleared by the FDA?
Esis Module (K780043) received a 510(k) decision of Substantially Equivalent on February 13, 1978, 35 days after the submission was received.
What is the product code of K780043?
The FDA product code is DRR – Amplifier And Signal Conditioner, Biopotential, a Class II (moderate risk) device regulated under 21 CFR 870.2050.