1085 Ultimate E Plethysmograph
FDA 510(k) K943259 · Medical Graphics Corp.
510(k) numberK943259
Submission
- Device name
- 1085 Ultimate E Plethysmograph
- Applicant
- Medical Graphics Corp.
St. Paul, MN, US - Received
- July 6, 1994
- Decision date
- April 10, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CCM – Plethysmograph, Pressure
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1750
- Specialty
- Anesthesiology
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Questions and answers
When was 1085 Ultimate E Plethysmograph cleared by the FDA?
1085 Ultimate E Plethysmograph (K943259) received a 510(k) decision of Substantially Equivalent on April 10, 1995, 278 days after the submission was received.
What is the product code of K943259?
The FDA product code is CCM – Plethysmograph, Pressure, a Class II (moderate risk) device regulated under 21 CFR 868.1750.