Merivaara Obstetric Chair/Bed-Model 358
FDA 510(k) K862931 · Global Medical Prods, Inc.
510(k) numberK862931
Submission
- Device name
- Merivaara Obstetric Chair/Bed-Model 358
- Applicant
- Global Medical Prods, Inc.
Chicago, IL, US - Received
- August 4, 1986
- Decision date
- August 7, 1986
- 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 |
| K861030 | Labor-Delivery Stretch/BedKNC · Traditional | Adel Medical , Ltd. | 04/23/1986SE |
More from Adel Medical , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K962329 | Global Loss of Resistance Syringe Glor 10FMF · Traditional | 09/12/1996SE |
| K961324 | Global Medical Products Spinal,Conical Tip (Sprottle Style), Whitacre Style NeedlesMIA · Traditional | 07/02/1996SE |
| K952275 | Global Medical Products Tuohy & Crawford Epidural Needle W/Plastic HubBSP · Traditional | 10/11/1995SE |
| K934256 | Global Medical Cutting Biopsy NeedleFCG · Traditional | 03/28/1994SE |
| K871556 | Merivaara Emergency Patient Trolley #436FPO · Traditional | 04/30/1987SE |
| K863748 | Hospital BedFNJ · Traditional | 10/09/1986SE |
| K862959 | Merivaara Patient Trolley - Model #416FPO · Traditional | 09/25/1986SE |
| K862957 | Merivaara Geriatric Chair Model 455INN · Traditional | 08/21/1986SE |
Questions and answers
When was Merivaara Obstetric Chair/Bed-Model 358 cleared by the FDA?
Merivaara Obstetric Chair/Bed-Model 358 (K862931) received a 510(k) decision of Substantially Equivalent on August 7, 1986, 3 days after the submission was received.
What is the product code of K862931?
The FDA product code is KNC – Table, Obstetric (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.4900.