Nasal Interface Model 7910
FDA 510(k) K974453 · Healthdyne Technologies, Inc.
510(k) numberK974453
Submission
- Device name
- Nasal Interface Model 7910
- Applicant
- Healthdyne Technologies, Inc.
Marietta, GA, US - Received
- November 25, 1997
- Decision date
- August 4, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- BZD – Ventilator, Non-Continuous (Respirator)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5905
- Specialty
- Anesthesiology
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Questions and answers
When was Nasal Interface Model 7910 cleared by the FDA?
Nasal Interface Model 7910 (K974453) received a 510(k) decision of Substantially Equivalent on August 4, 1998, 252 days after the submission was received.
What is the product code of K974453?
The FDA product code is BZD – Ventilator, Non-Continuous (Respirator), a Class II (moderate risk) device regulated under 21 CFR 868.5905.