Syringe 500BC Be #7000
FDA 510(k) K830898 · Instrumentation Industries, Inc.
510(k) numberK830898
Submission
- Device name
- Syringe 500BC Be #7000
- Applicant
- Instrumentation Industries, Inc.
Mchenry, IL, US - Received
- March 21, 1983
- Decision date
- May 16, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BXW – Calibrator, Volume, Gas
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.1870
- Specialty
- Anesthesiology
Other 510(k)s with product code BXW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K853848 | Respiratory Diagnostic Equipment CalibratorBXW · Traditional | Medical Graphics Corp. | 12/05/1985SE |
| K831758 | Flow-Calibration ModuleBXW · Traditional | The Perkin-Elmer Corp. | 07/19/1983SE |
| K812765 | Datascribe #DS-40BXW · Traditional | Timeter Instrument Corp. | 11/16/1981SE |
| K810290 | Ohio Cal-ChekBXW · Traditional | Ohio Medical Products | 02/12/1981SE |
| K760520 | Calipers, Mcgaw SkinfoldBXW · Traditional | Mcgaw Laboratories | 11/12/1976SE |
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Questions and answers
When was Syringe 500BC Be #7000 cleared by the FDA?
Syringe 500BC Be #7000 (K830898) received a 510(k) decision of Substantially Equivalent on May 16, 1983, 56 days after the submission was received.
What is the product code of K830898?
The FDA product code is BXW – Calibrator, Volume, Gas, a Class I (low risk) device regulated under 21 CFR 868.1870.