LIFELINE(R) PERSONAL RESPONSE SYSTEM
FDA 510(k) clearance K914103 · decided 1991-09-27
Clearance details
- K-number
- K914103
- Device name
- LIFELINE(R) PERSONAL RESPONSE SYSTEM
- Applicant
- Lifeline Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-09-12
- Decision date
- 1991-09-27
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- ILQ
- Device class
- 2
- Regulation number
- 890.3710
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- North Attleboro, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Philips GoSafe Mobile Help Button; 7000MHB. Personal Emergency Response System. recall (Z-0004-2016) | Lifeline Systems, Incorporated | 2015-10-01 |
| Philips GoSafe Communicator 7000L Personal emergency response system. recall (Z-1987-2015) | Lifeline Systems, Incorporated | 2015-07-06 |
| Philips Lifeline Personal Help Button Pendant Classic and Slimline Style. recall (Z-0419-2010) | Philips Lifeline Inc | 2009-11-25 |