Biochem 9100 Multigas Monitor Ibp Module
FDA 510(k) K921388 · Biochem International, Inc.
510(k) numberK921388
Submission
- Device name
- Biochem 9100 Multigas Monitor Ibp Module
- Applicant
- Biochem International, Inc.
Waukesha, WI, US - Received
- March 23, 1992
- Decision date
- May 26, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DSK – Computer, Blood-Pressure
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1110
- Specialty
- Cardiovascular
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Questions and answers
When was Biochem 9100 Multigas Monitor Ibp Module cleared by the FDA?
Biochem 9100 Multigas Monitor Ibp Module (K921388) received a 510(k) decision of Substantially Equivalent on May 26, 1993, 429 days after the submission was received.
What is the product code of K921388?
The FDA product code is DSK – Computer, Blood-Pressure, a Class II (moderate risk) device regulated under 21 CFR 870.1110.