510(k) K915779 ยท KNC Table, Obstetric (And Accessories)
AFFINITY BED MODEL 3600 SERIES
| Applicant | Hill-Rom, Inc., Batesville IN, US |
| Decision | Substantially Equivalent, Feb 24, 1993 |
| Received | Dec 24, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K915779
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 28, 2021 | Hill-Rom, Inc. Affinity Four Birthing Bed-used as a birthing bed for women of child bearing age in an LDR (Labor, Delivery, Recovery) or LDRP (Labor, Delivery, Recovery, Postpartum) setting within the acute care Lab Terminated |
KNC | None listed |
| Sep 8, 2016 | Hill-Rom, Inc. Affinity Four Birthing Bed Model P3700
The primary packaging is pictured below, and utilizes a metal packing brace, standard corrugated cardboard and plastic banding. When possible these beds are s Terminated |
KNC | None listed |
| Sep 1, 2014 | Hill-Rom, Inc. Affinity Four Birthing Bed,
Product Usage:
Product is intended to be used as birthing beds for women of child bearing age in an LDR (Labor, Delivery, Recovery) or LDRP (Labor, Delivery, Recovery, Po Terminated |
KNC | None listed |
| Dec 17, 2009 | Hill-Rom, Inc. Hill-Rom Affinity Four Birthing Bed, Hill-Rom Company, Inc., Batesville, Indiana; Model P3700B.
Intended to be used as birthing beds for momen of child bearing age in an labor, delivery, recovery or Terminated |
HDD | None listed |
| Apr 2, 2008 | Hill-Rom, Inc. Hill-Rom Affinity 4 Birthing Bed; Model P3700B, Hill-Rom, Inc., Batesville, IN 47006 Terminated |
HDD | None listed |
| Feb 22, 2008 | Hill-Rom, Inc. Hill-Rom Affinity Birthing Bed, Model P3600. Terminated |
KNC | None listed |
| Feb 22, 2008 | Hill-Rom, Inc. Hill-Rom Affinity Two Birthing Bed, Model P3600. Terminated |
KNC | None listed |
| Feb 22, 2008 | Hill-Rom, Inc. Hill-Rom Affinity Three Birthing Bed, Model P3700A. Terminated |
KNC | None listed |
| Feb 22, 2008 | Hill-Rom, Inc. Hill-Rom Affinity Four Birthing Bed, Model P3700B. Note: Not distributed in the U.S. Terminated |
KNC | None listed |
| Sep 14, 2006 | Hill-Rom, Inc. Hill-Rom Affinity Three Birthing Bed, Model P3700. Terminated |
KNC | None listed |
| May 29, 2003 | Hill-Rom, Inc. Hill-Rom brand Affinity three birthing bed Terminated |
KNC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.