Model 7700A/77010A/77025A/77030A/77035A Ultra Imag
FDA 510(k) K913827 · Hewlett-Packard Co.
510(k) numberK913827
Submission
- Device name
- Model 7700A/77010A/77025A/77030A/77035A Ultra Imag
- Applicant
- Hewlett-Packard Co.
Andover, MA, US - Received
- August 26, 1991
- Decision date
- November 19, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DPW – Flowmeter, Blood, Cardiovascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2100
- Specialty
- Cardiovascular
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Questions and answers
When was Model 7700A/77010A/77025A/77030A/77035A Ultra Imag cleared by the FDA?
Model 7700A/77010A/77025A/77030A/77035A Ultra Imag (K913827) received a 510(k) decision of Substantially Equivalent on November 19, 1991, 85 days after the submission was received.
What is the product code of K913827?
The FDA product code is DPW – Flowmeter, Blood, Cardiovascular, a Class II (moderate risk) device regulated under 21 CFR 870.2100.