Bronchodilator Tee - 9056 Series
FDA 510(k) K873521 · Boehringer Laboratories
510(k) numberK873521
Submission
- Device name
- Bronchodilator Tee - 9056 Series
- Applicant
- Boehringer Laboratories
Norristown, PA, US - Received
- September 1, 1987
- Decision date
- March 2, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CAF – Nebulizer (Direct Patient Interface)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5630
- Specialty
- Anesthesiology
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Questions and answers
When was Bronchodilator Tee - 9056 Series cleared by the FDA?
Bronchodilator Tee - 9056 Series (K873521) received a 510(k) decision of Substantially Equivalent on March 2, 1988, 183 days after the submission was received.
What is the product code of K873521?
The FDA product code is CAF – Nebulizer (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5630.