Astro-Med ASC-951 Pressure Processor
FDA 510(k) K894295 · Astro-Med, Inc.
510(k) numberK894295
Submission
- Device name
- Astro-Med ASC-951 Pressure Processor
- Applicant
- Astro-Med, Inc.
West Warwick, RI, US - Received
- June 23, 1989
- Decision date
- January 18, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DRQ – Amplifier And Signal Conditioner, Transducer Signal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2060
- Specialty
- Cardiovascular
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Questions and answers
When was Astro-Med ASC-951 Pressure Processor cleared by the FDA?
Astro-Med ASC-951 Pressure Processor (K894295) received a 510(k) decision of Substantially Equivalent on January 18, 1990, 209 days after the submission was received.
What is the product code of K894295?
The FDA product code is DRQ – Amplifier And Signal Conditioner, Transducer Signal, a Class II (moderate risk) device regulated under 21 CFR 870.2060.