BE#6006 Var. Resis. Inspir. Muscle
FDA 510(k) K821492 · Instrumentation Industries, Inc.
510(k) numberK821492
Submission
- Device name
- BE#6006 Var. Resis. Inspir. Muscle
- Applicant
- Instrumentation Industries, Inc.
Mchenry, IL, US - Received
- May 18, 1982
- Decision date
- September 24, 1982
- 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 BE#6006 Var. Resis. Inspir. Muscle cleared by the FDA?
BE#6006 Var. Resis. Inspir. Muscle (K821492) received a 510(k) decision of Substantially Equivalent on September 24, 1982, 129 days after the submission was received.
What is the product code of K821492?
The FDA product code is BWF – Spirometer, Therapeutic (Incentive), a Class II (moderate risk) device regulated under 21 CFR 868.5690.