Apm Dispos. Blood Pressure Transducer
FDA 510(k) K851888 · Honeywell, Inc.
510(k) numberK851888
Submission
- Device name
- Apm Dispos. Blood Pressure Transducer
- Applicant
- Honeywell, Inc.
Pleasantville, NY, US - Received
- May 1, 1985
- Decision date
- August 6, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DRS – Transducer, Blood-Pressure, Extravascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2850
- Specialty
- Cardiovascular
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Questions and answers
When was Apm Dispos. Blood Pressure Transducer cleared by the FDA?
Apm Dispos. Blood Pressure Transducer (K851888) received a 510(k) decision of Substantially Equivalent on August 6, 1985, 97 days after the submission was received.
What is the product code of K851888?
The FDA product code is DRS – Transducer, Blood-Pressure, Extravascular, a Class II (moderate risk) device regulated under 21 CFR 870.2850.