Atlas FDA

AFFINITY BED MODEL 3600 SERIES

FDA 510(k) clearance K915779 · decided 1993-02-24

Clearance details

K-number
K915779
Device name
AFFINITY BED MODEL 3600 SERIES
Applicant
Hill-Rom, Inc.
Decision
Substantially Equivalent
Date received
1991-12-24
Decision date
1993-02-24
Days to decision
428 days
Clearance type
Traditional
Product code
KNC
Device class
2
Regulation number
884.4900
Medical specialty
Obstetrics/Gynecology
Advisory committee
Obstetrics/Gynecology
Location
Batesville, IN, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
L720 EXAMINATION CHAIR (K001261)Luneau Gynecologie SA2000-06-08
NON-LINTING DELIVERY BLANKET (K932035)Amsco Sterile Recoveries, Inc.1994-05-26
MEDICAL DISPOSABLE BEDDING (K924420)Hill-Rom, Inc.1993-12-10
BD6000 THE OPTIMA & BD5000 BIRTHING BED (K914544)Lic Care, Inc.1993-11-24
GARDOSI BIRTHING CUSHION (K903973)Graphic Controls Corp.1990-09-27
OBSTETRICAL SAFETY SYSTEM (K884868)Buckman Co., Inc.1989-03-01
STRYKER MODEL 977 BIRTHING BED (K870745)Stryker Corp.1987-02-27
PALMER OBSTETRIC BRACE (K864194)Ad-Tech Medical Instrument Corp1987-01-14
MERIVAARA OBSTETRIC CHAIR/BED-MODEL 358 (K862931)Global Medical Prods, Inc.1986-08-07
LABOR-DELIVERY STRETCH/BED (K861030)Adel Medical , Ltd.1986-04-23
MERIVAARA OBSTETRIC CHAIR/BED MODEL 358 (K852174)Daun International, Inc.1985-09-06
CAT. NO. S-5300-E BIRTHING BED (K852171)Shampaine/Wilson1985-08-30

Recalls involving this device

RecordFirmDate
Affinity Four Birthing Bed Model P3700 The primary packaging is pictured below, and utiliz recall (Z-2750-2016)Hill-Rom, Inc.2016-09-08
Affinity Four Birthing Bed, Product Usage: Product is intended to be used as birthing beds recall (Z-2562-2014)Hill-Rom, Inc.2014-09-01
Hill-Rom Affinity Four Birthing Bed, Hill-Rom Company, Inc., Batesville, Indiana; Model P3 recall (Z-0548-2010)Hill-Rom, Inc.2009-12-17
Hill-Rom Affinity 4 Birthing Bed; Model P3700B, Hill-Rom, Inc., Batesville, IN 47006 recall (Z-0617-2008)Hill-Rom, Inc.2008-04-02
Hill-Rom Affinity Birthing Bed, Model P3600. recall (Z-0581-2008)Hill-Rom, Inc.2008-02-22
Hill-Rom Affinity Two Birthing Bed, Model P3600. recall (Z-0582-2008)Hill-Rom, Inc.2008-02-22
Hill-Rom Affinity Three Birthing Bed, Model P3700A. recall (Z-0583-2008)Hill-Rom, Inc.2008-02-22
Hill-Rom Affinity Four Birthing Bed, Model P3700B. Note: Not distributed in the U.S. recall (Z-0584-2008)Hill-Rom, Inc.2008-02-22
Hill-Rom Affinity Three Birthing Bed, Model P3700. recall (Z-1503-06)Hill-Rom, Inc.2006-09-14
Hill-Rom brand Affinity three birthing bed recall (Z-0902-03)Hill-Rom, Inc.2003-05-29