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FDA 510(k)

4200 PNEUMATIC MOUTH SHUTTER

K-Number: K791705 · 1979-10-04

ApplicantHans Rudolph, Inc.
Decision Date1979-10-04
Product CodeCCM
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

4200 PNEUMATIC MOUTH SHUTTER is the device name listed in this FDA 510(k) record. The listed applicant is Hans Rudolph, Inc.. It received FDA 510(k) clearance on 1979-10-04 under 510(k) number K791705. The device is classified under product code CCM. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 4200 PNEUMATIC MOUTH SHUTTER?

4200 PNEUMATIC MOUTH SHUTTER is a medical device that received FDA 510(k) clearance on 1979-10-04. The listed applicant is Hans Rudolph, Inc.. The 510(k) number is K791705.

When did 4200 PNEUMATIC MOUTH SHUTTER receive FDA 510(k) clearance?

4200 PNEUMATIC MOUTH SHUTTER received FDA 510(k) clearance on 1979-10-04, under 510(k) number K791705.

Who is the listed applicant for 4200 PNEUMATIC MOUTH SHUTTER?

The FDA 510(k) record lists Hans Rudolph, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 4200 PNEUMATIC MOUTH SHUTTER?

The FDA product code for 4200 PNEUMATIC MOUTH SHUTTER is CCM.

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Other records listing Hans Rudolph, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K071149HRI 6500, 6600 AND 6700 SERIES V2MASKSK0308227600 SERIES MULTI-PATIENT MULTI-USE ORO-NASAL CPAP/NPPV MASKSK030515HANS RUDOLPH 7500 SERIES REUSABLE ORO-NASAL NIV MASKSK0207597600 SERIES REUSABLE FULL-FACE CPAP/NIPPV MASKS MODELS 7620 LARGE, 7630 MEDIUM, 7640 SMALL, 7650 EXTRA SMALL, 7660 PETITK962848HANS RUDOLPH NASAL CPAP MASKK960401ULTIMATE SEAL

View all 11 devices →

Related Devices (Code: CCM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K081823MASTERSCREEN PAED - BABY BODYViasys Healthcare GmbHK023796MS PAED-BABY BODYErich Jaeger GmbHK9432591085 ULTIMATE E PLETHYSMOGRAPHMedical Graphics Corp.K893420MASTERLAB PFT AND MASTERLAB BODY BOXQuinton, Inc.K853390INFANT BODY TESTErich Jaeger, Inc.K852102COLLIN BODY PLETHYSMOGRAPH PLUS SYSTEMWarren E. Collins, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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