Hematocrit-Saturation Monitor HSM-100
FDA 510(k) K852124 · American Bentley
510(k) numberK852124
Submission
- Device name
- Hematocrit-Saturation Monitor HSM-100
- Applicant
- American Bentley
Irvine, CA, US - Received
- May 15, 1985
- Decision date
- September 16, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DRY – Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4330
- Specialty
- Cardiovascular
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Questions and answers
When was Hematocrit-Saturation Monitor HSM-100 cleared by the FDA?
Hematocrit-Saturation Monitor HSM-100 (K852124) received a 510(k) decision of Substantially Equivalent on September 16, 1985, 124 days after the submission was received.
What is the product code of K852124?
The FDA product code is DRY – Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4330.