Model 15055A Mainframe
FDA 510(k) K791964 · Hewlett-Packard Co.
510(k) numberK791964
Submission
- Device name
- Model 15055A Mainframe
- Applicant
- Hewlett-Packard Co.
Mchenry, IL, US - Received
- October 1, 1979
- Decision date
- October 11, 1979
- 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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| K894735 | ASC-952 Physiological AmplifierDRR · Traditional | Astro-Med, Inc. | 09/18/1989SE |
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| K874441 | Bard Biopotential AmplifierDRR · Traditional | C.R. Bard, Inc. | 01/19/1988SE |
| K853652 | BERS-400A Electrophysiological Amplifiers & InputDRR · Traditional | Fisher Imaging Corp. | 01/16/1986SE |
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Questions and answers
When was Model 15055A Mainframe cleared by the FDA?
Model 15055A Mainframe (K791964) received a 510(k) decision of Substantially Equivalent on October 11, 1979, 10 days after the submission was received.
What is the product code of K791964?
The FDA product code is DRR – Amplifier And Signal Conditioner, Biopotential, a Class II (moderate risk) device regulated under 21 CFR 870.2050.