AFFINITY BED MODEL 3600 SERIES— 510(k) K915779
Substantially EquivalentHill-Rom, Inc.
FDA 510(k) clearance K915779 for AFFINITY BED MODEL 3600 SERIES, Substantially Equivalent on 1993-02-24. Applicant: Hill-Rom, Inc.. Device class: 2.
Clearance details
- Applicant
- Hill-Rom, Inc.
- Product code
- Code KNC
- Device class
- Class 2
- Regulation
- 21 CFR 884.4900
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Batesville, IN, US
Recent devices under product code KNC
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Recalls naming K915779
K-number listed on FDA's recall record- Z-2156-2021 — 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 Labor and Delivery market Model Numbers: P3700B, P3700C, P3700D, & P3700E
- Z-2750-2016 — 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 shipped as a quantity of two (2) together as shown with the nylon strapping. These are shipped in standard freight containers. There is no secondary packaging.
- Z-2562-2014 — 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, Postpartum) setting within the acute care Labor and Delivery market.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K915779.
Data sourced from openFDA. This site is unofficial and independent of the FDA.