ASC-952 Physiological Amplifier
FDA 510(k) K894735 · Astro-Med, Inc.
510(k) numberK894735
Submission
- Device name
- ASC-952 Physiological Amplifier
- Applicant
- Astro-Med, Inc.
West Warwick, RI, US - Received
- July 27, 1989
- Decision date
- September 18, 1989
- 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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| K971570 | Epxpress System (Timberwolf Revision) /000391DRR · Traditional | Quinton Electrophysiology Corp. | 12/29/1997SE |
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| K914381 | Horizon 9000/HIS Option AmplifierDRR · Traditional | Mennen Medical, Inc. | 01/28/1992SE |
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| K894161 | ASC-950 ECG AmplifierDRR · Traditional | Astro-Med, Inc. | 08/03/1989SE |
| 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 |
| K813123 | Epc FilterDRR · Traditional | Codman & Shurtleff, Inc. | 11/27/1981SE |
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| K970951 | Grass Brainwave SoftwareOLV · Traditional | 05/19/1997SE |
| K963669 | Grass Model 15 Neurodata Amplifier SystemGWL · Traditional | 12/12/1996SE |
| K934644 | K3 SystemDRT · Traditional | 11/01/1994SE |
| K912929 | Dash IVDSF · Traditional | 08/13/1991SE |
| K896164 | ASC-954 Integrator AmplifierGWK · Traditional | 01/22/1990SE |
| K894295 | Astro-Med ASC-951 Pressure ProcessorDRQ · Traditional | 01/18/1990SE |
| K894736 | MT96000 Paper Chart RecorderDSF · Traditional | 12/13/1989SE |
Questions and answers
When was ASC-952 Physiological Amplifier cleared by the FDA?
ASC-952 Physiological Amplifier (K894735) received a 510(k) decision of Substantially Equivalent on September 18, 1989, 53 days after the submission was received.
What is the product code of K894735?
The FDA product code is DRR – Amplifier And Signal Conditioner, Biopotential, a Class II (moderate risk) device regulated under 21 CFR 870.2050.