← Product Code [FRN](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRN) · K961263 # MODEL 1200 ABMULATORY INFUSION PUMP (K961263) _Patient Solutions, Inc. · FRN · Aug 23, 1996 · General Hospital · ST_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRN/K961263 ## Device Facts - **Applicant:** Patient Solutions, Inc. - **Product Code:** [FRN](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRN.md) - **Decision Date:** Aug 23, 1996 - **Decision:** ST - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.5725 - **Device Class:** Class 2 - **Review Panel:** General Hospital - **Attributes:** Therapeutic ## Indications for Use The PSI Model 1200 ambulatory infusion pump is a multifunction pump designed to manage a wide variety of intravenous fluid profiles. ## Device Story Model 1200 ambulatory infusion pump; portable device for hospital, clinic, or home care use. Administers intravenous fluids via dedicated disposables and accessories. Operated by clinicians or patients to manage various fluid profiles. Provides controlled fluid delivery; supports clinical decision-making by ensuring accurate infusion therapy. Benefits patient through mobility and consistent fluid management. ## Technological Characteristics Portable ambulatory infusion pump; uses dedicated disposables and accessories. Design, materials, and components similar to predicate devices. ## Regulatory Identification An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm. ## Predicate Devices - Sabratek 6060 Homerun - Abbott Aim ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} AUG 23 1996 K941263 # APPENDIX F Patient Solutions Inc. # MODEL 1200 510(k) Summary 261 {1} 13220 Evening Creek Dr. So. Suite #114 San Diego, CA 92128 619-679-3840 FAX 619-679-3844 # 510(k) SUMMARY Submitter's Name: Patient Solutions Inc.(PSI) Address: 13220 Evening Creek Dr. So. Suite #114 San Diego, California 92128 Phone: (619) 679-3840 Contact: Tom Kane Date of Summary: April 1, 1996 Name of Device: Model 1200 Ambulatory Infusion Pump Legally Marketed Device to Which Substantially Equivalency Is Claimed: Sabratek 6060 Homerun and Abbott Aim ## Description of Device: The PSI Model 1200 is a small portable ambulatory infusion pump intended for hospital, clinic and home care use. It uses dedicated disposables and related accessories. ## Intended Use: The PSI Model 1200 ambulatory infusion pump is a multifunction pump designed to manage a wide variety of intravenous fluid profiles. ## Technological Characteristics The PSI, Sabratek and Abbott ambulatory infusion pumps all have the same general design and incorporate similar technologies, materials, and components. The primary function of the PSI Model 1200 is the same as the Sabratek 6060 and Abbott Aim, to administer fluids to a patient. The technological characteristics of the devices are the same and raise no new questions of safety and effectiveness. PSI concludes that the PSI Model 1200 is substantially equivalent to the Sabratek 6060 and Abbott Aim in providing infusion fluid therapy for the same clinical purposes that require the use of an ambulatory infusion pump. 262 --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRN/K961263](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FRN/K961263) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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