Palmer Obstetric Brace
FDA 510(k) K864194 · Ad-Tech Medical Instrument Corp
510(k) numberK864194
Submission
- Device name
- Palmer Obstetric Brace
- Applicant
- Ad-Tech Medical Instrument Corp
Racine, WI, US - Received
- October 27, 1986
- Decision date
- January 14, 1987
- 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 |
| K862931 | Merivaara Obstetric Chair/Bed-Model 358KNC · Traditional | Global Medical Prods, Inc. | 08/07/1986SE |
| K861030 | Labor-Delivery Stretch/BedKNC · Traditional | Adel Medical , Ltd. | 04/23/1986SE |
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| K181544 | Anchor Bolt (as an accessory to Depth Electrodes)GZL · Traditional | 08/09/2018SE |
| K170442 | Cranial Drill Bits and AccessoriesHBE · Traditional | 09/07/2017SE |
| K163355 | Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer…GZL · Traditional | 04/12/2017SE |
| K152769 | Fremap ElectrodeETN · Traditional | 05/06/2016SE |
| K152547 | DNAP ElectrodeGZL · Traditional | 03/04/2016SE |
| K112094 | Brain Biopsy NeedleHAW · Traditional | 04/24/2012SE |
| K053363 | Dual-Sided Interhemispheric Subdural Electrodes, Grid Subdural Electrodes…GYC · Abbreviated | 05/30/2006SE |
Questions and answers
When was Palmer Obstetric Brace cleared by the FDA?
Palmer Obstetric Brace (K864194) received a 510(k) decision of Substantially Equivalent on January 14, 1987, 79 days after the submission was received.
What is the product code of K864194?
The FDA product code is KNC – Table, Obstetric (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.4900.