629V Spirometer, Pulmonary Function Analyzer
FDA 510(k) K881402 · American Electromedics Corp.
510(k) numberK881402
Submission
- Device name
- 629V Spirometer, Pulmonary Function Analyzer
- Applicant
- American Electromedics Corp.
Hudson, NH, US - Received
- April 4, 1988
- Decision date
- September 26, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BZG – Spirometer, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1840
- Specialty
- Anesthesiology
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Questions and answers
When was 629V Spirometer, Pulmonary Function Analyzer cleared by the FDA?
629V Spirometer, Pulmonary Function Analyzer (K881402) received a 510(k) decision of Substantially Equivalent on September 26, 1988, 175 days after the submission was received.
What is the product code of K881402?
The FDA product code is BZG – Spirometer, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 868.1840.