Atlas FDA

FORECASTER

FDA 510(k) clearance K810832 · decided 1981-06-24

Clearance details

K-number
K810832
Device name
FORECASTER
Applicant
Forecaster Co.
Decision
Substantially Equivalent
Date received
1981-03-25
Decision date
1981-06-24
Days to decision
91 days
Clearance type
Traditional
Product code
LHD
Device class
U
Medical specialty
Unknown
Advisory committee
Unknown
Location
Mchenry, IL, US
Third-party review
No
Expedited review
No

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

RecordFirmDate
Ava Fertility Tracker (K200163)Ava AG2021-01-19
OVUSENSE (K122337)Fertility Focus, Ltd.2013-08-06
DUOFERTILITY (K102499)Cambridge Temperature Concepts , Ltd.2011-12-20
LADY COMP USA (K050094)Lady Comp USA2006-04-20
MICROLIFE DIGITAL BASAL THERMOMETER, MODEL MT 1921 (K030961)Microlife Corp.2003-09-12
PETIT SOPHIA (K021978)Nishitomo Co., Inc.2003-04-08
TCOYF FERTILITY SOFTWARE VERSION 1.0 (K002726)Ovusoft, LLC2001-04-06
MEDI-AID BASAL THERMOMETER (K952756)Polymedica Industries, Inc.1995-09-25
B-D DIGITAL THERMOMETER (K945427)Bd Becton Dickinson Vacutainer Systems Preanalytic1995-06-15
BIOSELF 2000 FERTILITY INDICATOR (K904211)Bioself, Inc.1992-10-14
L SOPHIA (K901512)Nishitomo Co., Inc.1990-07-20
FERTILITY FORECASTER COMPUTER PROGRAM (K880618)Fertile Time, Ltd.1988-06-24

Recalls involving this device

No recalls on record reference this clearance.