Amplifier Module, 78211A ECG
FDA 510(k) K772132 · Hewlett-Packard Co.
510(k) numberK772132
Submission
- Device name
- Amplifier Module, 78211A ECG
- Applicant
- Hewlett-Packard Co.
Mchenry, IL, US - Received
- November 14, 1977
- Decision date
- November 22, 1977
- 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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Questions and answers
When was Amplifier Module, 78211A ECG cleared by the FDA?
Amplifier Module, 78211A ECG (K772132) received a 510(k) decision of Substantially Equivalent on November 22, 1977, 8 days after the submission was received.
What is the product code of K772132?
The FDA product code is DRR – Amplifier And Signal Conditioner, Biopotential, a Class II (moderate risk) device regulated under 21 CFR 870.2050.