PPV VAPORIZER (MODIFICATION)
Device Facts
| Record ID | K960944 |
|---|---|
| Device Name | PPV VAPORIZER (MODIFICATION) |
| Applicant | Penlon , Ltd. |
| Product Code | CAD · Anesthesiology |
| Decision Date | Apr 2, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5880 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Device Story
Penlon PPV Vaporizers are anesthesia delivery devices used to vaporize anesthetic agents. Device incorporates safety features to prevent incorrect or overfilling, including an air lock, agent-specific fillers, a visual level indicator, and an overspill passage. Operated by clinicians in clinical settings to deliver precise concentrations of anesthetic agents to patients.
Clinical Evidence
Bench testing only; compliance with ASTM F1161:1988 Clause 12 verified via testing of sample vaporizers.
Technological Characteristics
Anesthesia vaporizer; features agent-specific fillers, air lock, and overspill protection. Complies with ASTM F1161:1988 Clause 12.
Regulatory Classification
Identification
An anesthetic vaporizer is a device used to vaporize liquid anesthetic and deliver a controlled amount of the vapor to the patient.
Related Devices
- K172702 — Tec 820, Tec 850 · Datex-Ohmeda, Inc. · Jan 4, 2018
- K150167 — V60 Anesthetic Vaporizer · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jun 30, 2015
- K042276 — D-VAPOR · Draeger Medical, Inc. · Sep 23, 2004
- K053564 — KEYED FILLER BOTTLE ADAPTOR, MODELS 53450, 53452, 53453, 53454 · Penlon Limited · Mar 3, 2006
- K981773 — DRAGER-VAPOR 19.3 · Draeger Medical, Inc. · Jul 6, 1998
Submission Summary (Full Text)
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Your Ref:
Our Ref:
Penlon
Inter Med
K960944
# ATTACHMENT 5
APR - 2 1990
Penlon Limited
Radley Road
Abingdon
Oxon OX14 3PH
Telephone: Abingdon (01235) 554222
Fax: (01235) 555252
Sales Fax: (01235) 555900
Telex Agency: 826715 AERO G
Cables: Penlon Abingdon
# SUMMARY OF SAFETY AND EFFECTIVENESS
This 510(K) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990, and in connection with our supplement in respect of the Penlon PPV Vaporizers.
1. Compliance With Standards
We confirm that sample vaporizers have been subjected to the tests listed in ASTM F1161:1988 Clause 12, and have been shown to comply with this standard. We also confirm that the test equipment and test conditions used complied with Clause 4 of this standard.
The User Manual has been examined and contains the information required by the above standard.
2. An appendix to the hazard analysis has been performed on the design, based on study of literature and evaluation reports, together with in-house experience covering more than 30 years' manufacture and marketing of vaporizers.
3. The test work to show compliance with ASTM F1161:1988 Clause 12 has been extended to cover the external influences noted during the hazard analysis appendix and the results are incorporated as WARNINGS, Caution or Information in the User Manual
(a) Vaporizer filling instructions clarification 12.1.13
4. Incorrect and overfilling protection is provided by the combination of (a) an air lock; (b) agent specific fillers; (c) level indicator with visual indication; (d) an overspill passage open during filling.
. . . /2
Registered Office:
Silvertown House
Vincent Square
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## Attachment 5 cont'd
We certify that this summary only includes information which is included in the 510(K) supplement submission.
for PENLON LIMITED
Alan Clemen
Alan C Green
Technical Director
6 Feb 1996
