Datascope Passport Monitor with CO2
FDA 510(k) K921526 · Datascope Corp.
510(k) numberK921526
Submission
- Device name
- Datascope Passport Monitor with CO2
- Applicant
- Datascope Corp.
Paramus, NJ, US - Received
- March 31, 1992
- Decision date
- October 14, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1400
- Specialty
- Anesthesiology
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Questions and answers
When was Datascope Passport Monitor with CO2 cleared by the FDA?
Datascope Passport Monitor with CO2 (K921526) received a 510(k) decision of Substantially Equivalent on October 14, 1992, 197 days after the submission was received.
What is the product code of K921526?
The FDA product code is CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, a Class II (moderate risk) device regulated under 21 CFR 868.1400.