Asthma Monitor
FDA 510(k) K960078 · Erich Jaeger, Inc.
510(k) numberK960078
Submission
- Device name
- Asthma Monitor
- Applicant
- Erich Jaeger, Inc.
Hoechberg, Germany, DE - Received
- January 5, 1996
- Decision date
- September 20, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- BZG – Spirometer, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1840
- Specialty
- Anesthesiology
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| K980876 | Asthma Monitor AM2BZG · Traditional | 08/14/1998SE |
| K972419 | Toennies Neuroscreen SystemIKN · Traditional | 04/30/1998SE |
| K954140 | Masterscreen IosBZG · Traditional | 12/14/1995SE |
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Questions and answers
When was Asthma Monitor cleared by the FDA?
Asthma Monitor (K960078) received a 510(k) decision of Substantially Equivalent on September 20, 1996, 259 days after the submission was received.
What is the product code of K960078?
The FDA product code is BZG – Spirometer, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 868.1840.