Ambu RMT Valve
FDA 510(k) K873579 · Ambu, Inc.
510(k) numberK873579
Submission
- Device name
- Ambu RMT Valve
- Applicant
- Ambu, Inc.
Hanover, MD, US - Received
- September 3, 1987
- Decision date
- December 30, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BWF – Spirometer, Therapeutic (Incentive)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5690
- Specialty
- Anesthesiology
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Questions and answers
When was Ambu RMT Valve cleared by the FDA?
Ambu RMT Valve (K873579) received a 510(k) decision of Substantially Equivalent on December 30, 1987, 118 days after the submission was received.
What is the product code of K873579?
The FDA product code is BWF – Spirometer, Therapeutic (Incentive), a Class II (moderate risk) device regulated under 21 CFR 868.5690.