Submission Details
| 510(k) Number | K981265 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 07, 1998 |
| Decision Date | June 23, 1998 |
| Days to Decision | 77 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
PAGEWRITER 200I INTERPRETIVE CARDIOGRAPH MODEL M1770A WITH ACUTE CARDIAC ISCHEMIA TIME INSENSITIVE PREDICTIVE INSTRUMENA
Jun 1998
Decision
77d
Days
—
Risk
About This 510(k) Submission
K981265 is an FDA 510(k) clearance for the PAGEWRITER 200I INTERPRETIVE CARDIOGRAPH MODEL M1770A WITH ACUTE CARDIAC ISCHEMIA TIME INSENSITIVE PREDICTIVE INSTRUMENA, submitted by Hewlett-Packard Co. (North Attleboro, US). The FDA issued a Cleared decision on June 23, 1998, 77 days after receiving the submission on April 7, 1998. This device falls under the Cardiovascular review panel.
Device Classification
| Product Code | LOS |
| Device Class | — |
Manufacturer
Similar Devices — LOS
All 82
K090895 · Bionet Co., Ltd.
· Aug 2009
K083749 · Qrs Diagnostic, LLC
· Mar 2009
K073376 · Philips Medical Systems
· Apr 2008
K023034 · Bionet Company, Ltd.
· Nov 2002
K011328 · Bionet Company, Ltd.
· Nov 2001
K993616 · Nasiff Assoc., Inc.
· Apr 2000
More from Hewlett-Packard Co.
View all
K992543
· MKJ · May 2000
K993587
· MQS · Jan 2000
K993169
· DRG · Dec 1999
K992977
· MKJ · Dec 1999
K993516
· DSI · Nov 1999