O.N.A.T.
FDA 510(k) K820175 · Latex Medical Devices, Inc.
510(k) numberK820175
Submission
- Device name
- O.N.A.T.
- Applicant
- Latex Medical Devices, Inc.
Bloomington, IN, US - Received
- January 21, 1982
- Decision date
- January 29, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KNC – Table, Obstetric (And Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.4900
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code KNC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K001261 | L720 Examination ChairKNC · Traditional | Luneau Gynecologie SA | 06/08/2000SE |
| K932035 | Non-Linting Delivery BlanketKNC · Traditional | Amsco Sterile Recoveries, Inc. | 05/26/1994SE |
| K924420 | Medical Disposable BeddingKNC · Traditional | Hill-Rom, Inc. | 12/10/1993SE |
| K914544 | BD6000 the Optima & BD5000 Birthing BedKNC · Traditional | Lic Care, Inc. | 11/24/1993SE |
| K915779 | Affinity Bed Model 3600 SeriesKNC · Traditional | Hill-Rom, Inc. | 02/24/1993SE |
| K903973 | Gardosi Birthing CushionKNC · Traditional | Graphic Controls Corp. | 09/27/1990SE |
| K884868 | Obstetrical Safety SystemKNC · Traditional | Buckman Co., Inc. | 03/01/1989SE |
| K870745 | Stryker Model 977 Birthing BedKNC · Traditional | Stryker Corp. | 02/27/1987SE |
| K864194 | Palmer Obstetric BraceKNC · Traditional | Ad-Tech Medical Instrument Corp | 01/14/1987SE |
| K862931 | Merivaara Obstetric Chair/Bed-Model 358KNC · Traditional | Global Medical Prods, Inc. | 08/07/1986SE |
More from Global Medical Prods, Inc.
Questions and answers
When was O.N.A.T. cleared by the FDA?
O.N.A.T. (K820175) received a 510(k) decision of Substantially Equivalent on January 29, 1982, 8 days after the submission was received.
What is the product code of K820175?
The FDA product code is KNC – Table, Obstetric (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.4900.