Ohio Cal-Chek
FDA 510(k) K810290 · Ohio Medical Products
510(k) numberK810290
Submission
- Device name
- Ohio Cal-Chek
- Applicant
- Ohio Medical Products
Walker, MI, US - Received
- February 3, 1981
- Decision date
- February 12, 1981
- 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 |
| K830898 | Syringe 500BC Be #7000BXW · Traditional | Instrumentation Industries, Inc. | 05/16/1983SE |
| K812765 | Datascribe #DS-40BXW · Traditional | Timeter Instrument Corp. | 11/16/1981SE |
| K760520 | Calipers, Mcgaw SkinfoldBXW · Traditional | Mcgaw Laboratories | 11/12/1976SE |
More from Mcgaw Laboratories
| 510(k) | Device | Decision |
|---|---|---|
| K841733 | Ohio Waste Gas Scavenging ReservoirCBN · Traditional | 07/11/1984SE |
| K842003 | Ohio Waste Gas Scavenging InterfaceCBN · Traditional | 05/23/1984SE |
| K840356 | Ohio Unitrol II Anesthesia Gas MachineBSZ · Traditional | 04/20/1984SE |
| K841274 | Bag-To-Ventilator Selector ValveBSZ · Traditional | 04/13/1984SE |
| K840967 | Ohio Heat Reflecting PatchFMI · Traditional | 03/23/1984SE |
| K840858 | Ohio 3300 Infant Warmer SystemFMT · Traditional | 03/23/1984SE |
| K840857 | Ohio 3000 Infant Warmer SystemFMT · Traditional | 03/23/1984SE |
| K840453 | Medishield PVM RespirometerBZK · Traditional | 03/02/1984SE |
| K840452 | Premium Dabm Dispos. Anes. Breath MaskBSJ · Traditional | 02/17/1984SE |
| K833335 | Modulus II Anesthesia Gas MachineBSZ · Traditional | 11/14/1983SE |
Questions and answers
When was Ohio Cal-Chek cleared by the FDA?
Ohio Cal-Chek (K810290) received a 510(k) decision of Substantially Equivalent on February 12, 1981, 9 days after the submission was received.
What is the product code of K810290?
The FDA product code is BXW – Calibrator, Volume, Gas, a Class I (low risk) device regulated under 21 CFR 868.1870.