Ergo-Oxyscreen
FDA 510(k) K843841 · Erich Jaeger, Inc.
510(k) numberK843841
Submission
- Device name
- Ergo-Oxyscreen
- Applicant
- Erich Jaeger, Inc.
Rockford, IL, US - Received
- October 1, 1984
- Decision date
- December 27, 1984
- 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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| K980876 | Asthma Monitor AM2BZG · Traditional | 08/14/1998SE |
| K972419 | Toennies Neuroscreen SystemIKN · Traditional | 04/30/1998SE |
| K960078 | Asthma MonitorBZG · Traditional | 09/20/1996SE |
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Questions and answers
When was Ergo-Oxyscreen cleared by the FDA?
Ergo-Oxyscreen (K843841) received a 510(k) decision of Substantially Equivalent on December 27, 1984, 87 days after the submission was received.
What is the product code of K843841?
The FDA product code is BZG – Spirometer, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 868.1840.